510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912011Substantially Equivalent

Codman Skull Clamp

Cerenovus, Inc., Randolph MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912011 is the FDA 510(k) clearance record for CODMAN SKULL CLAMP, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code HBL (Holder, Head, Neurosurgical (Skull Clamp)). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K912011.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HBL Holder, Head, Neurosurgical (Skull Clamp)
Regulation
21 CFR 882.4460
Device class
Class II
Review panel
Neurology
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
510(k) summary
Statement
Third party review
No

Clearances, product code HBL

Trailing 12 months

FDA records hold no clearances under product code HBL in the trailing twelve months.

FDA records show no clearances under product code HBL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HBL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260