510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K962328Substantially Equivalent

Single Use Instrument Tray

Medcare Medical Group, Inc., East Swanzey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962328 is the FDA 510(k) clearance record for SINGLE USE INSTRUMENT TRAY, a class I device, cleared for Medcare Medical Group, Inc. on under FDA product code FSM (Tray, Surgical, Instrument). FDA records list 8 510(k) clearances for Medcare Medical Group, Inc., from to . As of , FDA records show no recalls naming K962328.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FSM Tray, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medcare Medical Group, Inc. 234 Old Homestead Hwy., East Swanzey NH
510(k) summary
Statement
Third party review
No

Clearances, product code FSM

Trailing 12 months

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

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