510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964181Substantially Equivalent

Spongetrac

Surgitrac Corp., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964181 is the FDA 510(k) clearance record for SPONGETRAC, a class I device, cleared for Surgitrac Corp. on under FDA product code MRL (Scale, Sponge, Surgical, Electrically-Powered). FDA records list one 510(k) clearance for Surgitrac Corp. As of , FDA records show no recalls naming K964181.

Clearance record

Decision date
Received
(131 days to decision)
Product code
MRL Scale, Sponge, Surgical, Electrically-Powered
Regulation
21 CFR 880.2740
Device class
Class I
Review panel
General Hospital
Applicant
Surgitrac Corp. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code MRL

Trailing 12 months

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

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