510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862494Substantially Equivalent

Polyester Sponge Pattie

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

K862494 is the FDA 510(k) clearance record for POLYESTER SPONGE PATTIE, a class II device, cleared for American Silk Sutures, Inc. on under FDA product code HBA (Neurosurgical Paddie). FDA records list 14 510(k) clearances for American Silk Sutures, Inc., from to . As of , FDA records show 4 recalls naming K862494.

Clearance record

Decision date
Received
(29 days to decision)
Product code
HBA Neurosurgical Paddie
Regulation
21 CFR 882.4700
Device class
Class II
Review panel
Neurology
Applicant
American Silk Sutures, Inc. 91 Nason Rd., Swampscott MA
Third party review
No

Clearances, product code HBA

Trailing 12 months

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

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