510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934320Substantially Equivalent

Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration

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

K934320 is the FDA 510(k) clearance record for MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION, a class II device, cleared for Mentor O & O, Inc. on under FDA product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered). FDA records list 18 510(k) clearances for Mentor O & O, Inc., from to . As of , FDA records show one recall naming K934320.

Clearance record

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

Clearances, product code HQR

Trailing 12 months

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

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