Dover Rob-Nel Catheter

by Tyco Healthcare 510(k)

Active United States

510(k) K040897

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK040897	Date20 Jul 2004Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K040897
FDA Product Code: KOD

Device Class: Class II
Regulation: 21 CFR Part 876.5130
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Other devices from Tyco Healthcare

Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662

Unclassified
Kendall Scd Express Kambia Thigh Length Tearaway Sleeve

Class II
Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe Open recall

Class II
Monoject Prefill Heparin Lock Flush Syringe

Class II
Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501

Class II
Dover 100% Silicone Foley Catheter with Temperature Sensor

Class II

See all devices from Tyco Healthcare →