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Papillotomy Knives

by Olympus Corp. 510(k)

Active United States

510(k) K780774

Overview

Papillotomy knives are unit electrosurgical endoscopic devices, with or without accessories, classified under product code KNS and regulation number 876.4300. They are substantially equivalent to a legally marketed device and were cleared via the traditional 510(k) pathway.

The device was submitted by Olympus Corp. of McHenry, Illinois, and received FDA 510(k) clearance on July 27, 1978, under K780774. It is classified as Class II with special controls and falls under the gastroenterology and urology medical specialties.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780774 Date27 Jul 1978ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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