Micro Drills

FDA 510(k) K821486 · Spire Medical, Inc.

Substantially Equivalent

510(k) numberK821486

Submission

Device name
Micro Drills
Applicant
Spire Medical, Inc.
Ventura, CA, US
Received
May 18, 1982
Decision date
June 9, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code GFG

510(k)DeviceApplicantDecision
K935225Mitek Modular Drill BitGFG · Traditional Mitek Surgical Products, Inc.04/07/1994SE
K821127Key DrillGFG · Traditional Key Medical, Inc.06/03/1982SE

More from Key Medical, Inc.

510(k)DeviceDecision
K821487Micro-Surgical Power Instrument Sys.GFA · Traditional 07/02/1982SE
K821485DermabradersGFF · Traditional 06/10/1982SE
K802503Micro-Sugical Power Instrument SystemEQJ · Traditional 10/31/1980SE
K802463Micro-Surgical Power Instrument SystemERL · Traditional 10/31/1980SE

Questions and answers

When was Micro Drills cleared by the FDA?

Micro Drills (K821486) received a 510(k) decision of Substantially Equivalent on June 9, 1982, 22 days after the submission was received.

What is the product code of K821486?

The FDA product code is GFG – Bit, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4820.