510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934583Substantially Equivalent

Burrs

American Medical Specialties, Inc., Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934583 is the FDA 510(k) clearance record for BURRS, a class I device, cleared for American Medical Specialties, Inc. on under FDA product code GFF (Bur, Surgical, General & Plastic Surgery). FDA records list 4 510(k) clearances for American Medical Specialties, Inc., from to . As of , FDA records show no recalls naming K934583.

Clearance record

Decision date
Received
(125 days to decision)
Product code
GFF Bur, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
American Medical Specialties, Inc. 1080 Holcomb Bridge Rd.., Roswell GA
510(k) summary
Statement
Third party review
No

Clearances, product code GFF

Trailing 12 months

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

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