510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903878Substantially Equivalent

Mentor(r) Durastat(tm) Autoclav Bipolar Hemostat

Mentor O & O, Inc., Norwell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903878 is the FDA 510(k) clearance record for MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT, a class II device, cleared for Mentor O & O, Inc. on under FDA product code HQQ (Apparatus, Cautery, Radiofrequency, Battery-Powered). FDA records list 18 510(k) clearances for Mentor O & O, Inc., from to . As of , FDA records show no recalls naming K903878.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HQQ Apparatus, Cautery, Radiofrequency, Battery-Powered
Regulation
21 CFR 886.4100
Device class
Class II
Review panel
Ophthalmic
Applicant
Mentor O & O, Inc. 3000 Longwater Dr., Norwell MA
Third party review
No

Clearances, product code HQQ

Trailing 12 months

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

FDA records show no clearances under product code HQQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQQ, 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