Snap Reciprocating Saw

FDA 510(k) K935357 · Surgiquip, Inc.

Substantially Equivalent

510(k) numberK935357

Submission

Device name
Snap Reciprocating Saw
Applicant
Surgiquip, Inc.
Tulsa, OK, US
Received
November 4, 1993
Decision date
January 28, 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
GAF – Spatula, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K023688Lemaitre Vascular Disposable Vein StripperGAF · Traditional LeMaitre Vascular, Inc.01/30/2003SE
K890374Abdominal SpatulaGAF · Traditional Kinetic Medical Products02/03/1989SE
K882793PMT Fukushima Microsurgical Instrument LineGAF · Traditional Pmt Corp.07/18/1988SE
K822108Cement-PickGAF · Traditional Bio-Blitz, Inc.08/11/1982SE

More from Bio-Blitz, Inc.

510(k)DeviceDecision
K935517Snap Sternum SawHAB · Traditional 03/10/1994SE
K935322Snap Bone ReamerHWE · Traditional 01/28/1994SE
K935516Snap DrillHWE · Traditional 01/27/1994SE
K931769Snap Oscillating SawGFA · Traditional 01/27/1994SE

Questions and answers

When was Snap Reciprocating Saw cleared by the FDA?

Snap Reciprocating Saw (K935357) received a 510(k) decision of Substantially Equivalent on January 28, 1994, 85 days after the submission was received.

What is the product code of K935357?

The FDA product code is GAF – Spatula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.