FDA 510(k)

CODMAN SKULL CLAMP

K-Number: K912011 · 1991-07-31

Decision Date1991-07-31

Product CodeHBL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CODMAN SKULL CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1991-07-31 under 510(k) number K912011. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN SKULL CLAMP?

CODMAN SKULL CLAMP is a medical device that received FDA 510(k) clearance on 1991-07-31. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K912011.

When did CODMAN SKULL CLAMP receive FDA 510(k) clearance?

CODMAN SKULL CLAMP received FDA 510(k) clearance on 1991-07-31, under 510(k) number K912011.

Who is the listed applicant for CODMAN SKULL CLAMP?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODMAN SKULL CLAMP?

The FDA product code for CODMAN SKULL CLAMP is HBL.

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Other records listing Codman & Shurtleff, Inc. as applicant

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Related Devices (Code: HBL)

K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbH K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbH K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.