510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K930109Substantially Equivalent

Komet Medical Surgical Power Accesories

Brassler USA, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930109 is the FDA 510(k) clearance record for KOMET MEDICAL SURGICAL POWER ACCESORIES, a class II device, cleared for Brassler USA on under FDA product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment). FDA records list one 510(k) clearance for Brassler USA. As of , FDA records show no recalls naming K930109.

Clearance record

Decision date
Received
(226 days to decision)
Product code
JDX Instrument, Surgical, Sonic And Accessory/Attachment
Regulation
21 CFR 888.4580
Device class
Class II
Review panel
Orthopedic
Applicant
Brassler USA 55 Northern Blvd., Suite 301, Great Neck NY
510(k) summary
Statement
Third party review
No

Clearances, product code JDX

Trailing 12 months

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

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