510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963160Substantially Equivalent

Hx-5/6-1 Endoscopic Clipping Device

OLYMPUS Corporation of the Americas, Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963160 is the FDA 510(k) clearance record for HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, a class II device, cleared for Olympus America, Inc. on under FDA product code PKL (Hemostatic Metal Clip For The Gi Tract). FDA's definition for product code PKL reads: "Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding...". FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K963160.

Clearance record

Decision date
Received
(317 days to decision)
Product code
PKL Hemostatic Metal Clip For The Gi Tract
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Summary
Third party review
No

Clearances, product code PKL

Trailing 12 months
8 clearances under product code PKL in the twelve months to November 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code PKL, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20261
September 20261
October 20262
November 20260