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
K872806Substantially Equivalent

Stick Sponge, Strung Tonsil Sponge Double Strung

American Silk Sutures, Inc., Lynn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872806 is the FDA 510(k) clearance record for STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG, cleared for American Silk Sutures, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 14 510(k) clearances for American Silk Sutures, Inc., from to . As of , FDA records show one recall naming K872806.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
American Silk Sutures, Inc. 57 Munroe St., Lynn MA
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