Medical Device Manufacturer · US , Ledyard , CT

American Silk Sutures, Inc.

14 submissions · 14 cleared · Since 1985

14

Total

14

Cleared

0

Denied

American Silk Sutures, Inc. — FDA 510(k) Submissions

American Silk Sutures, Inc. has submitted 14 FDA 510(k) premarket notifications since 1985, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Neurosurgical Paddie, Gauze/sponge, Internal, X-ray Detectable, Gauze/sponge, Internal, Cotton, Roll, Splint, Nasal . Use the specialty filter in the sidebar to narrow results.

14 devices

1–14 of 14

AMERICAN BURN SHEET

K922143 · KME Bedding, Disposable, Medical · General Hospital

STRUNG TELFA NON-ADHERENT SPONGE

K904514 · HBA Neurosurgical Paddie · Neurology

RAYON NEUROLOGICAL SPONGE

K902921 · HBA Neurosurgical Paddie · Neurology

STRUNG DENTAL ROLLS

K872810 · EFN Cotton, Roll · Dental

AMERICAN BRAIN RETRACTOR COVER

K872951 · GET Motor, Surgical... · General & Plastic Surgery

AMERICAN NASAL SPONGE

K872905 · EPP Splint, Nasal · Ear, Nose, Throat

SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE

K872906 · GEA Cannula, Surgical,... · General & Plastic Surgery

STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG

K872806 · EFQ Gauze/sponge, Internal · General & Plastic Surgery

NON-WOVEN TRACHEOTOMY SPONGE

K872807 · GDY Gauze/sponge, Internal,... · General & Plastic Surgery

CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8

K872808 · EFQ Gauze/sponge, Internal · General & Plastic Surgery

GAUZE CHERRY SPONGE

K872809 · GDY Gauze/sponge, Internal,... · General & Plastic Surgery

POLYESTER SPONGE PATTIE

K862494 · HBA Neurosurgical Paddie · Neurology

COTTON NEUROLOGICAL SPONGE

K854713 · HBA Neurosurgical Paddie · Neurology

X-RAY DETECTABLE COTTON BALLS

K854714 · GDY Gauze/sponge, Internal,... · General & Plastic Surgery