510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962789Substantially Equivalent

Surgical Kit-Acufex Mosaicplasty System

Smith & Nephew Endoscopy, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962789 is the FDA 510(k) clearance record for SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM, a class I device, cleared for Smith & Nephew Endoscopy, Inc. on under FDA product code GEY (Motor, Surgical Instrument, Ac-Powered). FDA records list 18 510(k) clearances for Smith & Nephew Endoscopy, Inc., from to . As of , FDA records show no recalls naming K962789.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GEY Motor, Surgical Instrument, Ac-Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Smith & Nephew Endoscopy, Inc. 130 Forbes Blvd., Mansfield MA
510(k) summary
Summary
Third party review
No

Clearances, product code GEY

Trailing 12 months

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

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