Codman Disposable Skull Pins

FDA 510(k) K911723 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK911723

Submission

Device name
Codman Disposable Skull Pins
Applicant
Codman & Shurtleff, Inc.
Randolph, MA, US
Received
April 17, 1991
Decision date
September 10, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Specialty
Neurology

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Questions and answers

When was Codman Disposable Skull Pins cleared by the FDA?

Codman Disposable Skull Pins (K911723) received a 510(k) decision of Substantially Equivalent on September 10, 1991, 146 days after the submission was received.

What is the product code of K911723?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.