← Product Code [MND](/submissions/GU/subpart-e%E2%80%94surgical-devices/MND) · K964661 # HX-20/21-1 ENDOSCOPIC LIGATOR (K964661) _Olympus America, Inc. · MND · Oct 30, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K964661 ## Device Facts - **Applicant:** Olympus America, Inc. - **Product Code:** [MND](/submissions/GU/subpart-e%E2%80%94surgical-devices/MND.md) - **Decision Date:** Oct 30, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4400 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use Olympus HX-20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop designed to prevent or control bleeding following polypectomy of pedunculated polyps. ## Device Story Endoscopic accessory used with Olympus endoscopes; delivers ligation loops (MAJ-254 or MAJ-340) to pedunculated polyps post-polypectomy. Operates via through-the-scope technique to prevent or control bleeding. Used by clinicians in endoscopic procedures. Provides mechanical ligation to secure polyp stalks. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Endoscopic accessory; through-the-scope delivery system for ligation loops; compatible with Olympus endoscopes; mechanical operation. ## 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 - Endoscopic Ligators by C.R. Bard - Endoscopic Ligators by Wilson-Cook - Endoscopic Ligators by Microvasive ## 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} To: Mary J. Cornelius Page 2 of 4 Thursday, October 23, 1997 4:07:15 PM K 964661 OCT 30 1997 # 510(k) SUMMARY ## OLYMPUS HX-20-1 ENDOSCOPIC LIGATOR **Device Name:** Olympus HX-20-1 Endoscopic Ligator **Common/Usual Name:** HX-20-1 Endoscopic Ligator **Classification Name:** Endoscope and Accessories 21 CFR 876.1500 **Predicate Device:** Endoscopic Ligators by C.R. Bard, Wilson-Cook, and Microvasive **Contact Person:** Laura Storms-Tyler Olympus America, Inc. Endoscope Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5688 **Summary Preparation Date:** October 22, 1997 ### Statement of Intended Use: Olympus HX-20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop designed to prevent or control bleeding following polypectomy of pedunculated polyps. ### Device Description: The Olympus HX-20-1 Endoscopic Ligator is intended to deliver a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop to prevent or control bleeding following polypectomy of pedunculated polyps. The Olympus “EndoLoop” is substantially equivalent in intended use to endoscopic ligators marketed by Bard, Microvasive, and Wilson-Cook. The subject ligating device differs from these devices in that it operates via through-the-scope techniques. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 30 1997 Ms. Laura Storms-Tyler Director, Regulatory Affairs Endoscopic Division Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157 Re: K964661 HX-20/21-1 Endoscopic Ligator Dated: September 3, 1997 Received: September 4, 1997 Regulatory class: II 21 CFR §876.4400/Product code: 78 FHN and MND Dear Ms. Storms-Tyler: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} To: Mary J. Cornelius Page 4 of 4 Thursday, October 23, 1997 4:08:36 PM # Indications for Use Statement 510(k) Number (if known): Not assigned yet K 964661 Device Name: Olympus HX-20-1 Endoscopic Ligator Indications for Use: The Olympus HX-20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop, designed to prevent or control bleeding following polypectomy of pedunculated polyps. (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K 964661 Prescription Use ☑ (Per 21 CFR 801.109) Over-the-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K964661](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MND/K964661) **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