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
K192468Substantially Equivalent

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; 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

Hangzhou Bever Medical Devices Co., Ltd., Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192468 is the FDA 510(k) clearance record for Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; 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, a class II device, cleared for Hangzhou Bever Medical Devices Co., Ltd. on under FDA product code GBM (Catheter, Urethral). FDA records list 4 510(k) clearances for Hangzhou Bever Medical Devices Co., Ltd., from to . As of , FDA records show one recall naming K192468.

Clearance record

Decision date
Received
(79 days to decision)
Product code
GBM Catheter, Urethral
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hangzhou Bever Medical Devices Co., Ltd. Bldg. 2, # 1-1, Houmuqiao, Yongle Village,, Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GBM

Trailing 12 months

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

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