Surgical Bur

FDA 510(k) K950449 · Transidyne General Corp.

Substantially Equivalent

510(k) numberK950449

Submission

Device name
Surgical Bur
Applicant
Transidyne General Corp.
Spartanburg, SC, US
Received
February 3, 1995
Decision date
March 1, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K862852Micro-Aire Replace Otology Burs/Zim Hall Sur InstrGFF · Traditional Micro-Aire Surgical Instruments, Inc.08/11/1986SE

More from Micro-Aire Surgical Instruments, Inc.

510(k)DeviceDecision
K961217Bodily Fluid Disposal KitFXX · Traditional 07/25/1996SE
K955658Laceration TrayFRG · Traditional 01/25/1996SE
K950773Prophylaxis PackEGS · Traditional 03/31/1995SESK
K950743Oral Procedure PackEGS · Traditional 03/31/1995SESK
K950403Surgical Saw BladesGFA · Traditional 02/21/1995SE
K924811I.V. Start KitLRS · Traditional 06/17/1993SEKD
K924243Tracheostomy Care KitJOH · Traditional 06/16/1993SEKD
K922339Suture Removal KitMCZ · Traditional 12/11/1992SESK
K922041Primary Surgical Dressing TrayFMF · Traditional 11/06/1992SEKD
K897133Model 1050 - Umbilical Cord Blood Sampling KitCBT · Traditional 03/30/1990SE

Questions and answers

When was Surgical Bur cleared by the FDA?

Surgical Bur (K950449) received a 510(k) decision of Substantially Equivalent on March 1, 1995, 26 days after the submission was received.

What is the product code of K950449?

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