Gardner Pins (Adult & Child)

FDA 510(k) K911772 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK911772

Submission

Device name
Gardner Pins (Adult & Child)
Applicant
Codman & Shurtleff, Inc.
Randolph, MA, US
Received
April 19, 1991
Decision date
August 26, 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 Gardner Pins (Adult & Child) cleared by the FDA?

Gardner Pins (Adult & Child) (K911772) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 129 days after the submission was received.

What is the product code of K911772?

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