510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062659Substantially Equivalent

Kirwan Disposable Battery-Powered Cautery, Model 41-61Xx Series

Kirwan Surgical Products, LLC, Marshfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062659 is the FDA 510(k) clearance record for KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES, a class II device, cleared for Kirwan Surgical Products, Inc. on under FDA product code HQP (Unit, Cautery, Thermal, Battery-Powered). FDA records list 19 510(k) clearances for Kirwan Surgical Products, Inc., from to . As of , FDA records show no recalls naming K062659.

Clearance record

Decision date
Received
(183 days to decision)
Product code
HQP Unit, Cautery, Thermal, Battery-Powered
Regulation
21 CFR 886.4115
Device class
Class II
Review panel
Ophthalmic
Applicant
Kirwan Surgical Products, Inc. 180 Enterprise Dr., Marshfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQP

Trailing 12 months

FDA records hold no clearances under product code HQP in the trailing twelve months.

FDA records show no clearances under product code HQP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260