510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K970020Substantially Equivalent

Simar, Inc. Surgical Dressing

Simar, Inc., Philadelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970020 is the FDA 510(k) clearance record for SIMAR, INC. SURGICAL DRESSING, cleared for Simar, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list one 510(k) clearance for Simar, Inc. As of , FDA records show no recalls naming K970020.

Clearance record

Decision date
Received
(76 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Simar, Inc. 6800 Lindbergh Blvd., Philadelphia PA
510(k) summary
Statement
Third party review
No

Clearances, product code EFQ

Trailing 12 months

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

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