Codman Skull Clamp

FDA 510(k) K912011 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK912011

Submission

Device name
Codman Skull Clamp
Applicant
Codman & Shurtleff, Inc.
Randolph, MA, US
Received
May 6, 1991
Decision date
July 31, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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 Skull Clamp cleared by the FDA?

Codman Skull Clamp (K912011) received a 510(k) decision of Substantially Equivalent on July 31, 1991, 86 days after the submission was received.

What is the product code of K912011?

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