← Product Code [MND](/submissions/GU/subpart-e%E2%80%94surgical-devices/MND) · K013066 # HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K013066) _Olympus America, Inc. · MND · Dec 11, 2001 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K013066 ## Device Facts - **Applicant:** Olympus America, Inc. - **Product Code:** [MND](/submissions/GU/subpart-e%E2%80%94surgical-devices/MND.md) - **Decision Date:** Dec 11, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4400 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use Endoscopic marking and hemostasis for: (a) mucosal/sub-mucosal defects <3cm, (b) bleeding ulcers, (c) arteries <2mm, (d) polyps <1.5cm in diameter, (e) diverticula in the colon, and (f) other lesions and to close GI tract luminal perforations <20mm that can be treated conservatively. ## Device Story The Olympus HX-5/6-1 is an endoscopic clipping device used by physicians to perform hemostasis and tissue marking within the gastrointestinal tract. The device consists of a delivery system and a rotatable clip. The operator inserts the device through an endoscope; the clip is deployed at the target site to mechanically grasp and hold tissue together. This action facilitates the closure of mucosal/sub-mucosal defects, bleeding ulcers, or perforations, and marks specific areas for identification. The rotatable feature allows the physician to orient the clip precisely before deployment. By providing mechanical closure, the device assists in managing GI bleeding and defects, potentially reducing the need for more invasive surgical interventions. ## Clinical Evidence No clinical data provided; substantial equivalence is based on design, intended use, and technological similarities to legally marketed predicate devices. ## Technological Characteristics The device is a mechanical endoscopic clipping system. It features a rotatable clip mechanism for tissue grasping and closure. It is designed for use through an endoscope. The device is provided sterile. ## Regulatory Identification A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid. ## Special Controls *Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. ## Predicate Devices - HX-5/6-1 Endoscopic Clipping Device ([K963160](/device/K963160.md)) - Olympus HX-5/6 Endoscopic Clipping Device ([K990687](/device/K990687.md)) ## 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 the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Olympus Optical Co., Ltd. % Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. 2 Corporate Center Drive Melville, NY 11747-3157 .JUI 2 7 2015 Re: K013066 > Trade/Device Name: Rotatable Clip Fixing Devices HX-5/6-1 Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: FHN, MND Dated (Date on orig SE ltr): September 10, 2001 Received (Date on orig SE ltr): September 12, 2001 Dear Ms. Storms-Tyler, This letter corrects our substantially equivalent letter of December 11, 2001 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 (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. 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 {1}------------------------------------------------ Page 2 - 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 2005/0000 : (uncouri i) Industrial (2) OLS Regulable Clip Fixing Devices RE-5/6-1 :58U 101 2008:00 Itextial Device Name: and the momend and chic clices commons sudantly one with beau อป of beagiesh และป จะเล่ โ-ประ-XH รวมงาน รูมที่มี ตุมันที่สุดที่ สุนักษ์เป็นที่มีใช้ (1) candoscopic marking and and and of the for the purpose of hempersis for (s) marcosal/gub-mucosal defects Olympus HX-5/6 Endoscopic Clipping Device #K990687 | {4}------------------------------------------------ Jo x Py "3010" ## D. 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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