← Product Code [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI) · K040961 # INJECTOR NEEDLE/SNARE (K040961) _United States Endoscopy Group, Inc. · FDI · Jul 8, 2004 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K040961 ## Device Facts - **Applicant:** United States Endoscopy Group, Inc. - **Product Code:** [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI.md) - **Decision Date:** Jul 8, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4300 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes. ## Device Story Dual lumen Injector Needle Share; used with flexible endoscope and Olympus or Microvasive active cord; enables submucosal injection for polyp lift, fluid infusion for field clearing, dye spray, clot removal, hemostatic agent delivery, and site tattooing. Operated by physicians in clinical settings. Device facilitates electrosurgical excision and diagnostic/therapeutic endoscopic interventions; improves visualization and procedural control. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Dual lumen design; compatible with flexible endoscopes and specific active cords (Olympus/Microvasive). Mechanical injection/infusion device. ## Regulatory Identification An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of an organization or agency. The symbol in the center consists of three curved lines that resemble a stylized bird or wave pattern. The logo is black and white and has a simple, clean design. JUL - 8 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Gretchen Y. Cohen Executive Vice President United States Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060 Re: K040961 : Trade/Device Name: Endoscopic Injection Needle/Snare, Models # 00711086 and 00711088 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: 78 FBK Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Product Code: 78 FDI Regulatory Class: II Dated: June 11, 2004 Received: June 14, 2004 Dear Ms. Cohen: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowe 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 for associated in the enactment date of 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, de rios that have ocen t tequire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may , aron's provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr rass made a over regulations administered by other Federal agencies. You must of any I ederal statutes and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Party) noceming (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ This letter will allow you to begin marketing; your device as described in your Section 5 (d(k) This letter will allow you to begin harreting, your and equivalence of your device to a legally premarket notification. The FDA inding, in basical on for your device and thus, pennits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Park (1), please If you desire specific advice for your decided on on the following numbers, based on the regulation number at the top of the letter. | 8xx. Ixxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and enote the regulation entitled, "Mastranding Office of Compliance at (301) 594-4639. Also, please note the international with Othice of Compliance at (501) 574-1657. Fab., promote of a production of Since by reference to premarked nouncation (21 ce Fee Act may be obtained from the Division of Small information on your responsibilities under the Act may be of Small Case and P information on your responsionalites and consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance in Assistances in Manufacturers, International and Collsamer Passential Passerial Statis (301) 443-6597 or at its Internet Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use ## 510(k) Number (if known): K040961 ## Device Name: Injector Needle Share ## Indications for Use: The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes. Prescription Use (Part 21 CFR 801 Subpart D) David h. Sepsom (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K040961](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K040961) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com