Dermabraders

FDA 510(k) K821485 · Spire Medical, Inc.

Substantially Equivalent

510(k) numberK821485

Submission

Device name
Dermabraders
Applicant
Spire Medical, Inc.
Ventura, CA, US
Received
May 18, 1982
Decision date
June 10, 1982
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
K883255Komet Surgical BurGFF · Traditional Komet Medical, Div. of Brasseler USA I, L.P.09/15/1988SE
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

More from Tava Surgical Instruments

510(k)DeviceDecision
K821487Micro-Surgical Power Instrument Sys.GFA · Traditional 07/02/1982SE
K821486Micro DrillsGFG · Traditional 06/09/1982SE
K802503Micro-Sugical Power Instrument SystemEQJ · Traditional 10/31/1980SE
K802463Micro-Surgical Power Instrument SystemERL · Traditional 10/31/1980SE

Questions and answers

When was Dermabraders cleared by the FDA?

Dermabraders (K821485) received a 510(k) decision of Substantially Equivalent on June 10, 1982, 23 days after the submission was received.

What is the product code of K821485?

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