510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K913233Substantially Equivalent

Codman Lhalo Split Ring Retractor System

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

K913233 is the FDA 510(k) clearance record for CODMAN LHALO SPLIT RING RETRACTOR SYSTEM, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K913233.

Clearance record

Decision date
Received
(9 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
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 GZT

Trailing 12 months
1 clearance under product code GZT in the twelve months to November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260