510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K770958Substantially Equivalent

Bandage, Unipress, Clarion

Sherwood Medical Industries, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770958 is the FDA 510(k) clearance record for BANDAGE, UNIPRESS, CLARION, a class I device, cleared for Sherwood Medical Industries on under FDA product code FQM (Bandage, Elastic). FDA records list 62 510(k) clearances for Sherwood Medical Industries, from to . As of , FDA records show no recalls naming K770958.

Clearance record

Decision date
Received
(18 days to decision)
Product code
FQM Bandage, Elastic
Regulation
21 CFR 880.5075
Device class
Class I
Review panel
General Hospital
Applicant
Sherwood Medical Industries 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FQM

Trailing 12 months

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

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