Panels › Gastroenterology, Urology › Product code GBM · Class 2
Catheter, Urethral
Regulation 876.5130
0510(k)s in 12 months (71 all time)
2recalls in 12 months (18 all time)
15recalls that name a 510(k)
Top companies in GBM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2026 | Hollister Ulc Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as:
1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081;
2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermi Open, Classified |
GBM | K211436 |
| Jan 12, 2026 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female
REF: RTU14F Open, Classified |
GBM | K192468 |
| Feb 16, 2024 | Cardinal Health 200, LLC Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD Open, Classified |
GBM | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device Open, Classified |
GBM | K760093 |
| Apr 12, 2018 | Teleflex Medical Europe Ltd Simplastic Suprapubic Puncture Instruments:
Product Code Equivalent Code
(a) 650704100 551310
(b) 650704120 551312
(c) 650704160 551316
Product Usage:
RUSCH Simplastic Supr Terminated |
GBM | None listed |
| Jun 3, 2011 | Coloplast Manufacturing US, LLC SpeediCath , SpeediCath with Accessories
Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark
284821 1400 SpeediCath, acc CH10 Male
284831 1400 SpeediCath, acc CH12 Male
Terminated |
GBM | None listed |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the b Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | K992137 |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | K992137 |
| Apr 17, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Cone Tip Ureteral Catheter (7 Fr x 70 cm)
Product Number: 400-213 Terminated |
GBM | K870694 |
| Apr 17, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x 70 cm)
Product Number: 400-212 Terminated |
GBM | K870694 |
| Apr 17, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm)
Product Number: 400-211 Terminated |
GBM | K870694 |
| Apr 17, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm)
Product Number: 400-203 Terminated |
GBM | K830840 |
| Apr 17, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm)
Product Number: 400-202 Terminated |
GBM | K830840 |
| Apr 17, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm)
Product Number: 400-201 Terminated |
GBM | K830840 |
| Apr 17, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm)
Product Number: 400-200 Terminated |
GBM | K830840 |
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