Komet Surgical Bur

FDA 510(k) K883255 · Komet Medical, Div. of Brasseler USA I, L.P.

Substantially Equivalent

510(k) numberK883255

Submission

Device name
Komet Surgical Bur
Applicant
Komet Medical, Div. of Brasseler USA I, L.P.
Savannah, GA, US
Received
August 2, 1988
Decision date
September 15, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GFF – Bur, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

Other 510(k)s with product code GFF

510(k)DeviceApplicantDecision
K974025Anspach Shielded AttachmentGFF · Traditional The Anspach Effort, Inc.07/06/1998SE
K950449Surgical BurGFF · Traditional Transidyne General Corp.03/01/1995SE
K943758Surgical BurGFF · Traditional Komet Medical08/22/1994SE
K934583BurrsGFF · Traditional American Medical Specialties, Inc.01/26/1994SE
K894438Micro-Aire Cutters for Midas-Rex InstrumentsGFF · Traditional Micro-Aire Surgical Instruments, Inc.08/21/1989SE
K890090Danek Irrigating Burr (Dib) SetGFF · Traditional Danek Medical, Inc.01/24/1989SE
K880859Surgical BursGFF · Traditional New England Surgical Instrument Corp.03/21/1988SE
K880706Surgical BursGFF · Traditional Nuell Air Equipment & Hospital Supplies, Inc.02/26/1988SE
K872475Surgical BurGFF · Traditional Tava Surgical Instruments07/02/1987SE
K862852Micro-Aire Replace Otology Burs/Zim Hall Sur InstrGFF · Traditional Micro-Aire Surgical Instruments, Inc.08/11/1986SE

Questions and answers

When was Komet Surgical Bur cleared by the FDA?

Komet Surgical Bur (K883255) received a 510(k) decision of Substantially Equivalent on September 15, 1988, 44 days after the submission was received.

What is the product code of K883255?

The FDA product code is GFF – Bur, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4820.