510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250066Substantially Equivalent

Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)

Boston Scientific Corporation, Marlborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250066 is the FDA 510(k) clearance record for Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612), a class II device, cleared for Boston Scientific Corporation 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 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K250066.

Clearance record

Decision date
Received
(27 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
Boston Scientific Corporation 100 Boston Scientific Way, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKL

Trailing 12 months
7 clearances under product code PKL in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PKL, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20261
September 20261
October 20260