510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831913Substantially Equivalent

Color-Eze Pre-Washed Lap Sponges

Ormed Mfg., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831913 is the FDA 510(k) clearance record for COLOR-EZE PRE-WASHED LAP SPONGES, a class I device, cleared for Ormed Mfg., Inc. on under FDA product code GDY (Gauze/Sponge, Internal, X-Ray Detectable). FDA records list 23 510(k) clearances for Ormed Mfg., Inc., from to . As of , FDA records show no recalls naming K831913.

Clearance record

Decision date
Received
(104 days to decision)
Product code
GDY Gauze/Sponge, Internal, X-Ray Detectable
Regulation
21 CFR 878.4450
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ormed Mfg., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GDY

Trailing 12 months

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

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