510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853658Substantially Equivalent

Burs for Micro Surgical Drill System

Acumed Instruments Corp., Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853658 is the FDA 510(k) clearance record for BURS FOR MICRO SURGICAL DRILL SYSTEM, a class I device, cleared for Acumed Instruments Corp. on under FDA product code GFF (Bur, Surgical, General & Plastic Surgery). FDA records list 8 510(k) clearances for Acumed Instruments Corp., from to . As of , FDA records show no recalls naming K853658.

Clearance record

Decision date
Received
(21 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
Acumed Instruments Corp. 345 Puente Dr., Santa Barbara CA
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