MPA · Endoilluminator
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | MPA |
|---|---|
| Device Name | Endoilluminator |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
(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.
Special Controls
*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.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Alcon Laboratories, Inc. | Dec 4, 2024 | SESE |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | Peregrine Surgical, LLC | Aug 5, 2024 | SESE |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | Nova Eye Inc. (Business Name Nova Eye Medical) | Mar 30, 2023 | SESE |
| K202670 | Nam illumination probe with chopper | Oculight , Ltd. | Aug 20, 2021 | SESE |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical , Ltd. | Sep 11, 2015 | SESE |
| K143123 | Synergetics PHOTON EX | Synergetics | Feb 24, 2015 | SESE |
| K080067 | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER | Iscience Interventional | Jul 18, 2008 | SESE |
| K062895 | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII | Dutch Ophthalmic Research Center International BV | Oct 13, 2006 | SESE |
| K062259 | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 | Iscience Surgical | Aug 15, 2006 | SESE |
| K041108 | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA | Iscience Surgical Corporation | Jun 22, 2004 | SESE |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Synergetics, Inc. | Nov 24, 2003 | SESE |
| K000252 | INSIGHT 4000 ENDOSCOPE | Insight Instruments Mfg., Inc. | Oct 17, 2000 | SESE |
| K000416 | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 | Retinalabs.Com | May 8, 2000 | SESE |
| K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | Peregrine Surgical , Ltd. | May 19, 1998 | SESE |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | Peregrine Surgical , Ltd. | May 12, 1998 | SESE |
| K980027 | PEREGRINE SHIELDED DIFFUSION PROBE | Peregrine Surgical , Ltd. | Mar 31, 1998 | SESE |
| K980025 | PEREGRINE TAPERED DIFFUSION PROBE | Peregrine Surgical , Ltd. | Mar 31, 1998 | SESE |
| K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM | Dutch Ophthalmic USA, Inc. | Nov 25, 1997 | SESE |
| K973293 | SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR | Vaughan Weeks | Nov 18, 1997 | SESE |
| K973290 | SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK | Vaughan Weeks | Nov 14, 1997 | SESE |
Top Applicants
- Gamp & Assoc. — 5 clearances
- Peregrine Surgical , Ltd. — 5 clearances
- American Medical Devices, Inc. — 3 clearances
- M.B. Industries, Inc. — 3 clearances
- Dutch Ophthalmic USA, Inc. — 2 clearances
