510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931626Substantially Equivalent

Carapace Sterile Cotton Balls

Carapace, Inc., Broken Arrow OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931626 is the FDA 510(k) clearance record for CARAPACE STERILE COTTON BALLS, a class I device, cleared for Carapace, Inc. on under FDA product code FRL (Fiber, Medical, Absorbent). FDA records list 22 510(k) clearances for Carapace, Inc., from to . As of , FDA records show no recalls naming K931626.

Clearance record

Decision date
Received
(244 days to decision)
Product code
FRL Fiber, Medical, Absorbent
Regulation
21 CFR 880.5300
Device class
Class I
Review panel
General Hospital
Applicant
Carapace, Inc. 2701 W Concord St., Broken Arrow OK
510(k) summary
Statement
Third party review
No

Clearances, product code FRL

Trailing 12 months

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

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