(284 days)
The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.
The Revolve Surgical System is an electromechanically controlled laparoscopic surgery platform used for minimally invasive surgery in the abdomen comprised of a reusable system arm which mounts to the operating table and several sterile, single-use disposable accessories – instrument, instrument handle, and drape. The device operates under the direct control of the surgeon to manipulate tissues during surgery. Surgeon control is achieved by grasping the instrument handle and moving it to the desired position. The device compensates for gravitational forces applied to the instrument and maintains the instrument position when the surgeon's hand is removed from the device.
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
Revolve Surgical Inc.
Alex Gordon
Chief Executive Officer
619-2 Carlton Street
Toronto, ON M5B1J3
Canada
Re: K243968
Trade/Device Name: Revolve Surgical System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: September 5, 2025
Received: September 5, 2025
Dear Alex Gordon:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
October 3, 2025
Page 2
Revolve Surgical Inc.
Alex Gordon
Chief Executive Officer
619-2 Carlton Street
Toronto, ON M5B1J3
Canada
October 3, 2025
Re: K243968
Trade/Device Name: Revolve Surgical System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: September 5, 2025
Received: September 5, 2025
Dear Alex Gordon:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
K243968 - Alex Gordon Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K243968 - Alex Gordon Page 3
Sincerely,
Colin K. Chen -S
Digitally signed by Colin K. Chen -S
Date: 2025.10.03 15:04:36 -04'00'
Colin Kejing Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243968
Device Name: Revolve Surgical System
Indications for Use (Describe)
The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Revolve Surgical Inc 510(k) SUMMARY
Revolve Surgical System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Revolve Surgical
619-2 Carlton Street
Toronto, Ontario, Canada
M5B 1J3
Phone: +1-647-884-4060
Contact Person: Alex Gordon
Date Prepared: October 02, 2025
Name of Device
Revolve Surgical System
Device Classification and Product Code
21 CFR 876.1500 — Endoscope and accessories. Class II; Product Code GCJ
Predicate Device
HX Device, Human Xtensions (K173919)
Reference Device
Maestro, Moon Surgical (K221410)
Device Description
The Revolve Surgical System is an electromechanically controlled laparoscopic surgery platform used for minimally invasive surgery in the abdomen comprised of a reusable system arm which mounts to the operating table and several sterile, single-use disposable accessories – instrument, instrument handle, and drape. The device operates under the direct control of the surgeon to manipulate tissues during surgery. Surgeon control is achieved by grasping the instrument handle and moving it to the desired position. The device compensates for gravitational forces applied to the instrument and maintains the instrument position when the surgeon's hand is removed from the device.
Indications for Use
The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.
Page 1 of 5
K243968
Page 6
Revolve Surgical Inc K243968
510(k) SUMMARY
Revolve Surgical System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Revolve Surgical
619-2 Carlton Street
Toronto, Ontario, Canada
M5B 1J3
Phone: +1-647-884-4060
Contact Person: Alex Gordon
Date Prepared: October 02, 2025
Name of Device
Revolve Surgical System
Device Classification and Product Code
21 CFR 876.1500 — Endoscope and accessories. Class II; Product Code GCJ
Predicate Device
HX Device, Human Xtensions (K173919)
Reference Device
Maestro, Moon Surgical (K221410)
Device Description
The Revolve Surgical System is an electromechanically controlled laparoscopic surgery platform used for minimally invasive surgery in the abdomen comprised of a reusable system arm which mounts to the operating table and several sterile, single-use disposable accessories – instrument, instrument handle, and drape. The device operates under the direct control of the surgeon to manipulate tissues during surgery. Surgeon control is achieved by grasping the instrument handle and moving it to the desired position. The device compensates for gravitational forces applied to the instrument and maintains the instrument position when the surgeon's hand is removed from the device.
Indications for Use
The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.
Page 1 of 5
Performance Data
The following performance data were provided in support of the substantial equivalence determination:
-
Software Verification & Validation
Software verification and validation tests were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
-
Electrical Safety and EMC
Electrical Safety per IEC 60601-1 and Electromagnetic Compatibility (EMC) per IEC 60601-1-2 were conducted on the Revolve Surgical System.
-
Sterilization, Cleaning, Packaging and Shelf-Life Testing
Manual cleaning, disinfection, and sterilization reprocessing methods were validated. Shelf and reuse life testing verified device performance was maintained after accelerated aging and simulated use testing.
-
Biocompatibility
All evaluation of biocompatibility was performed in compliance with ISO 10993-1.
-
Bench Testing
Bench testing included tests for:
-
System arm functionality, including but not limited to:
- Positioning, deflection, friction, and integrity
- Connection of accessories including all disposables
- Port alignment accuracy
- Gravity compensation accuracy
- Mounting to operating table
-
Instrument and handle functionality, including but not limited to:
- Deflection and integrity
- Input forces for user interfaces
- Performance including gripping and torque
- Port site forces
-
System functionality, including but not limited to:
- Brake state control
- LED indication during normal operation and error states
- Emergency stop
-
Fault conditions
-
-
Human Factors
Usability and human factors evaluation was performed per IEC 60601-1-6 and FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices".
Page 2 of 5
Page 7
Revolve Surgical Inc K243968
Performance Data
The following performance data were provided in support of the substantial equivalence determination:
-
Software Verification & Validation
Software verification and validation tests were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
-
Electrical Safety and EMC
Electrical Safety per IEC 60601-1 and Electromagnetic Compatibility (EMC) per IEC 60601-1-2 were conducted on the Revolve Surgical System.
-
Sterilization, Cleaning, Packaging and Shelf-Life Testing
Manual cleaning, disinfection, and sterilization reprocessing methods were validated. Shelf and reuse life testing verified device performance was maintained after accelerated aging and simulated use testing.
-
Biocompatibility
All evaluation of biocompatibility was performed in compliance with ISO 10993-1.
-
Bench Testing
Bench testing included tests for:
-
System arm functionality, including but not limited to:
- Positioning, deflection, friction, and integrity
- Connection of accessories including all disposables
- Port alignment accuracy
- Gravity compensation accuracy
- Mounting to operating table
-
Instrument and handle functionality, including but not limited to:
- Deflection and integrity
- Input forces for user interfaces
- Performance including gripping and torque
- Port site forces
-
System functionality, including but not limited to:
- Brake state control
- LED indication during normal operation and error states
- Emergency stop
-
Fault conditions
-
-
Human Factors
Usability and human factors evaluation was performed per IEC 60601-1-6 and FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices".
Page 2 of 5
Performance test results were analyzed to demonstrate substantially equivalent performance. All bench testing was performed under conditions that approximate the Revolve Surgical System's intended use: where necessary, abdominal phantoms were used. All testing passed in accordance with the pre-specified success criteria, FDA recognized standards or FDA guidance documents.
Page 3 of 5
Page 8
Revolve Surgical Inc K243968
Subject Device and Predicate Devices Comparison
| Revolve Surgical RSS Subject Device | Human Xtensions HX Device Predicate Device | Moon Surgical Maestro Device Reference Device | |
|---|---|---|---|
| Brief Description | The RSS is an electromechanically controlled laparoscopic device mounted to the operating room table. The device specific instrument (needle holder) is connected to the device and operated under the direct control of a surgeon to manipulate tissues during surgery. The RSS compensates for gravitational forces on instruments during use and maintains their position when surgeon hand force is removed. | The HX Device is a hand-held powered laparoscopic device that acts as a "surgeon's hand extension." The HX Device is electromechanically controlled and includes both hardware and software. It is comprised of two major parts, the Handpiece and the Instrument (grasper or needle holder). | The Maestro device is an electrically actuated device with movable components intended for laparoscopic surgical procedures to support and position laparoscopic instruments. Its major components consist of the Surgical Base, Surgical Arms, Control Unit, Instrument Coupling, and Control Station. |
| Indications for Use | The RSS is intended to assist in the control of RS laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use. | The HX Device is intended to assist in the control of HX laparoscopic instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use. | The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures. |
| Mounting | Mounted to OR table | Handheld | Mounted to cart positioned next to OR table |
| Mechanism of Action | Software and hardware maintain instrument position when surgeon hand force is removed | N/A | Software and hardware maintain instrument position when surgeon hand force is removed |
| Gravity compensation forces applied to laparoscopic instruments | N/A | Gravity compensation forces applied to laparoscopic instruments | |
| Motorized movement of end effectors | Motorized movement of end effectors | No motorized movement of instruments | |
| Insertion Method | Via 5mm Trocar | Via 5mm Trocar | N/A |
| Instrument Type | • Straight – single action – needle holder | • Articulated Fenestrated grasper • Articulated – single action – needle holder | N/A |
| Single Use / Reusable | Single-Use: Instrument, Instrument Handle, Drape Reusable: System Arm | Single-Use: Instruments, Arc, Pads, Spacer, Drape Reusable: Handpiece and Power Cable | Single Use: Drape Reusable: Surgical Base, Surgical Arms, Control Unit, Instrument Coupling, Control System |
| Sterile Components | Instrument, Instrument Handle, Drape | Instruments, Arc, Finger Pads, Spacer, Drape | Drape |
Page 4 of 5
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Revolve Surgical Inc K243968
Conclusion
The Revolve Surgical System has the same intended use as the predicate devices. The differences in technological characteristics do not raise different questions of safety or efficacy. Performance data demonstrates that the Revolve Surgical System performs as intended and, in a manner, that is substantially equivalent to the predicate device. Therefore, the Revolve Surgical System is substantially equivalent to the predicate device for the requested indications for use.
Page 5 of 5
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.