510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904352Substantially Equivalent

Codman Collins Radioparent Sternal Blades

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

K904352 is the FDA 510(k) clearance record for CODMAN COLLINS RADIOPARENT STERNAL BLADES, a class I device, cleared for Codman & Shurtleff, Inc. on under FDA product code DWH (Blade, Saw, Surgical, Cardiovascular). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K904352.

Clearance record

Decision date
Received
(58 days to decision)
Product code
DWH Blade, Saw, Surgical, Cardiovascular
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
Third party review
No

Clearances, product code DWH

Trailing 12 months

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

FDA records show no clearances under product code DWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWH, 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