510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832441Substantially Equivalent

Suture-Aid Booties

Omega-Med Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832441 is the FDA 510(k) clearance record for SUTURE-AID BOOTIES, a class I device, cleared for Omega-Med Intl., Inc. on under FDA product code KDC (Instrument, Surgical, Disposable). FDA records list 9 510(k) clearances for Omega-Med Intl., Inc., from to . As of , FDA records show no recalls naming K832441.

Clearance record

Decision date
Received
(224 days to decision)
Product code
KDC Instrument, Surgical, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Omega-Med Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KDC

Trailing 12 months

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

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