Snap Bone Reamer

FDA 510(k) K935322 · Surgiquip, Inc.

Substantially Equivalent

510(k) numberK935322

Submission

Device name
Snap Bone Reamer
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
HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

Other 510(k)s with product code HWE

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K143191IntelliSense DrillHWE · Traditional Mcginley Innovations02/20/2015SE
K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresHWE · Traditional Ortho Solutions Limited01/20/2011SE
K063688Surgical Irrigation System, Irrigation TubeHWE · Special The Anspach Effort, Inc.01/16/2007SE
K050766Explant Osteonecrosis Intervention Implant Removal SystemHWE · Traditional Zimmer Trabecular05/26/2005SE
K043310Synthes (USA) Electric Pen Drive SystemHWE · Traditional Synthes (Usa)01/05/2005SE
K022744Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional Medical Device Services09/18/2002SE
K012694Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional Adven Medical02/04/2002SE
K012676Reprocessed Used, Disposable Blades, Burs, Bits and TapsHWE · Traditional Adven Medical02/04/2002SE
K990816Avcore SystemHWE · Traditional Modular Cutting Systems, Inc.09/24/1999SE
K973736Aesculap Hilan Motor SystemHWE · Traditional Aesculap, Inc.12/29/1997SE

More from Aesculap, Inc.

510(k)DeviceDecision
K935517Snap Sternum SawHAB · Traditional 03/10/1994SE
K935357Snap Reciprocating SawGAF · Traditional 01/28/1994SE
K935516Snap DrillHWE · Traditional 01/27/1994SE
K931769Snap Oscillating SawGFA · Traditional 01/27/1994SE

Questions and answers

When was Snap Bone Reamer cleared by the FDA?

Snap Bone Reamer (K935322) 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 K935322?

The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.