510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802248Substantially Equivalent

Disarp Original

Unoplast A/S, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802248 is the FDA 510(k) clearance record for DISARP ORIGINAL, a class II device, cleared for Unoplast A/S on under FDA product code GAO (Suture, Nonabsorbable). FDA records list 7 510(k) clearances for Unoplast A/S, from to . As of , FDA records show no recalls naming K802248.

Clearance record

Decision date
Received
(10 days to decision)
Product code
GAO Suture, Nonabsorbable
Regulation
21 CFR 878.4495
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Unoplast A/S 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GAO

Trailing 12 months

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

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