510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K861699Substantially Equivalent

Catheter Valves Kv 100 & Kv 100Eh

Max Staubli, Ltd., Horgen, Switzerland, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861699 is the FDA 510(k) clearance record for CATHETER VALVES KV 100 & KV 100EH, a class II device, cleared for Max Staubli , Ltd. on under FDA product code KOD (Catheter, Urological). FDA records list one 510(k) clearance for Max Staubli , Ltd. As of , FDA records show no recalls naming K861699.

Clearance record

Decision date
Received
(198 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Max Staubli , Ltd. Spatzstrasse 14, Horgen, Switzerland, CH
Third party review
No

Clearances, product code KOD

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