510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880401Substantially Equivalent

Denver Peritoneo-Venous Shunt

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

K880401 is the FDA 510(k) clearance record for DENVER PERITONEO-VENOUS SHUNT, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code KPM (Shunt, Peritoneal). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K880401.

Clearance record

Decision date
Received
(123 days to decision)
Product code
KPM Shunt, Peritoneal
Regulation
21 CFR 876.5955
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
Third party review
No

Clearances, product code KPM

Trailing 12 months

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

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