510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801737Substantially Equivalent

Sternum Saw

Amsco Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801737 is the FDA 510(k) clearance record for STERNUM SAW, a class I device, cleared for Amsco Co. on under FDA product code KFK (Saw, Pneumatically Powered). FDA records list 4 510(k) clearances for Amsco Co., from to . As of , FDA records show no recalls naming K801737.

Clearance record

Decision date
Received
(26 days to decision)
Product code
KFK Saw, Pneumatically Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Amsco Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KFK

Trailing 12 months

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

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