Auto Suture Spinal Dissector

FDA 510(k) K942971 · United States Surgical, A Division of Tyco Healthc

Substantially Equivalent

510(k) numberK942971

Submission

Device name
Auto Suture Spinal Dissector
Applicant
United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US
Received
June 20, 1994
Decision date
July 20, 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
HAO – Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Specialty
Neurology

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K951492Rib ResectorHAO · Traditional United States Surgical, A Division of Tyco Healthc05/18/1995SE
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K942970Auto Suture Spinal ElevatorHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K942969Auto Suture Spinal Nerve HookHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K942968Auto Suture Spinal OsteotomeHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K942967Auto Suture Spinal CuretteHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
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More from Acra Cut, Inc.

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K061288Auto Suture Endo Clip III 5 MM Clip ApplierFZP · Special 11/02/2006SE
K062850Autosuture Circular Eea Surgical StaplersGDW · Special 10/23/2006SE
K062326Autosuture Modified Versaport Trocar with Fixation SleeveGCJ · Special 09/01/2006SE
K061095Auto Sutur Endo Gia StaplersGDW · Traditional 05/31/2006SE
K050947Modification to: Modified Uss Polypropylene SutureGAW · Special 06/01/2005SE
K042412Modified Spacemaker SystemGCJ · Special 09/24/2004SE
K040594Herculon Soft Tissue Reattachment SystemHWC · Special 03/31/2004SE
K032696Auto Suture Endoscopic (& Open) Ta Surgical Stapler, Auto Suture Endoscopic (& Open) Gia…GDW · Traditional 12/01/2003SE

Questions and answers

When was Auto Suture Spinal Dissector cleared by the FDA?

Auto Suture Spinal Dissector (K942971) received a 510(k) decision of Substantially Equivalent on July 20, 1994, 30 days after the submission was received.

What is the product code of K942971?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.