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
K071355Substantially Equivalent

Smartsponge System

Clearcount Medical Solutions, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071355 is the FDA 510(k) clearance record for SMARTSPONGE SYSTEM, a class I device, cleared for Clearcount Medical Solutions, Inc. on under FDA product code LWH (Counter, Sponge, Surgical). FDA records list 3 510(k) clearances for Clearcount Medical Solutions, Inc., from to . As of , FDA records show no recalls naming K071355.

Clearance record

Decision date
Received
(9 days to decision)
Product code
LWH Counter, Sponge, Surgical
Regulation
21 CFR 880.2740
Device class
Class I
Review panel
General Hospital
Applicant
Clearcount Medical Solutions, Inc. 700 River Ave., Suite 100, Pittsburgh PA
510(k) summary
Summary PDF
Third party review
Yes

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