Surgical Saw Blades

FDA 510(k) K934603 · American Medical Specialties, Inc.

Substantially Equivalent

510(k) numberK934603

Submission

Device name
Surgical Saw Blades
Applicant
American Medical Specialties, Inc.
Roswell, GA, US
Received
September 24, 1993
Decision date
February 22, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K931769Snap Oscillating SawGFA · Traditional Surgiquip, Inc.01/27/1994SE
K934390Oscillating Bone Saw Blade, 6200 SeriesGFA · Traditional Boehringer Laboratories01/26/1994SE

More from Boehringer Laboratories

510(k)DeviceDecision
K960483Steinman PinHTY · Traditional 04/09/1996SE
K960482K-WireHTY · Traditional 04/09/1996SE
K934583BurrsGFF · Traditional 01/26/1994SE

Questions and answers

When was Surgical Saw Blades cleared by the FDA?

Surgical Saw Blades (K934603) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 151 days after the submission was received.

What is the product code of K934603?

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