Snap Oscillating Saw

FDA 510(k) K931769 · Surgiquip, Inc.

Substantially Equivalent

510(k) numberK931769

Submission

Device name
Snap Oscillating Saw
Applicant
Surgiquip, Inc.
Austin, TX, US
Received
April 9, 1993
Decision date
January 27, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code GFA

510(k)DeviceApplicantDecision
K971978Graft Harvesting SawbladesGFA · Traditional Wrightmedicaltechnologyinc06/18/1997SE
K954483Stryker Sagittal Saw AttachmentGFA · Traditional Stryker Instruments01/30/1996SE
K955229Wright Medical Technology SawbladesGFA · Traditional Wrightmedicaltechnologyinc01/18/1996SE
K953012Disposable & Reusable Surgical Cutting ToolsGFA · Traditional Boston Surgical Products, Inc.07/12/1995SE
K950403Surgical Saw BladesGFA · Traditional Transidyne General Corp.02/21/1995SE
K940501Re-Sharpenable Saw BladesGFA · Traditional Adven Medical06/28/1994SE
K933595Bur, Surgical, General & Plastic SurgeryGFA · Traditional Omega Surgical Instruments, Inc.03/16/1994SE
K935391Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional 3M Health Care, Sarns02/24/1994SE
K934603Surgical Saw BladesGFA · Traditional American Medical Specialties, Inc.02/22/1994SE
K934390Oscillating Bone Saw Blade, 6200 SeriesGFA · Traditional Boehringer Laboratories01/26/1994SE

More from Boehringer Laboratories

510(k)DeviceDecision
K935517Snap Sternum SawHAB · Traditional 03/10/1994SE
K935357Snap Reciprocating SawGAF · Traditional 01/28/1994SE
K935322Snap Bone ReamerHWE · Traditional 01/28/1994SE
K935516Snap DrillHWE · Traditional 01/27/1994SE

Questions and answers

When was Snap Oscillating Saw cleared by the FDA?

Snap Oscillating Saw (K931769) received a 510(k) decision of Substantially Equivalent on January 27, 1994, 293 days after the submission was received.

What is the product code of K931769?

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