510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945144Substantially Equivalent

Sponge Count

Michael Fischer Assoc., Winnetka IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945144 is the FDA 510(k) clearance record for SPONGE COUNT, a class I device, cleared for Michael Fischer Assoc. on under FDA product code LWH (Counter, Sponge, Surgical). FDA records list one 510(k) clearance for Michael Fischer Assoc. As of , FDA records show no recalls naming K945144.

Clearance record

Decision date
Received
(84 days to decision)
Product code
LWH Counter, Sponge, Surgical
Regulation
21 CFR 880.2740
Device class
Class I
Review panel
General Hospital
Applicant
Michael Fischer Assoc. 1248 Pine St., Winnetka IL
510(k) summary
Statement
Third party review
No

Clearances, product code LWH

Trailing 12 months

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

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