510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923555Substantially Equivalent

Codman Gaab Neuroendoscope

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

K923555 is the FDA 510(k) clearance record for CODMAN GAAB NEUROENDOSCOPE, a class I device, cleared for Codman & Shurtleff, Inc. on under FDA product code GWB (Antisera, Fluorescent, All Types, Streptococcus Pneumoniae). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K923555.

Clearance record

Decision date
Received
(249 days to decision)
Product code
GWB Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
510(k) summary
Summary
Third party review
No

Clearances, product code GWB

Trailing 12 months

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

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