510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922143Substantially Equivalent

American Burn Sheet

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

K922143 is the FDA 510(k) clearance record for AMERICAN BURN SHEET, a class I device, cleared for American Silk Sutures, Inc. on under FDA product code KME (Bedding, Disposable, Medical). FDA records list 14 510(k) clearances for American Silk Sutures, Inc., from to . As of , FDA records show no recalls naming K922143.

Clearance record

Decision date
Received
(96 days to decision)
Product code
KME Bedding, Disposable, Medical
Regulation
21 CFR 880.6060
Device class
Class I
Review panel
General Hospital
Applicant
American Silk Sutures, Inc. 82 Sanderson Ave., Lynn MA
510(k) summary
Statement
Third party review
No

Clearances, product code KME

Trailing 12 months

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

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