Vanderbilt Blade Holder

FDA 510(k) K761097 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK761097

Submission

Device name
Vanderbilt Blade Holder
Applicant
Codman & Shurtleff, Inc.
Walker, MI, US
Received
November 22, 1976
Decision date
November 30, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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Questions and answers

When was Vanderbilt Blade Holder cleared by the FDA?

Vanderbilt Blade Holder (K761097) received a 510(k) decision of Substantially Equivalent on November 30, 1976, 8 days after the submission was received.

What is the product code of K761097?

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