Cleared Traditional

K192468 - Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter (FDA 510(k) Clearance)

Also includes:
Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter
K192468 · Hangzhou Bever Medical Devices Co., Ltd. · Gastroenterology & Urology device
Nov 2019
Decision
79d
Days
Class 2
Risk

K192468 is an FDA 510(k) clearance for the Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).

Submitted by Hangzhou Bever Medical Devices Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 27, 2019, 79 days after receiving the submission on September 9, 2019.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K192468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date November 27, 2019
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code GBM - Catheter, Urethral
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5130