Product code GBM
- Device name
- Catheter, Urethral
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co., Ltd. | 2025-03-05 |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | 2022-06-22 |
| K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | 2022-01-27 |
| K200820 | SpeediCath Compact Set | Coloplast | 2020-11-13 |
| K192904 | SpeediCath Compact Set | Coloplast | 2020-11-02 |
| K200142 | SpeediCath Soft | Coloplast | 2020-07-30 |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2020-06-01 |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | 2020-05-21 |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2020-05-07 |
| K193148 | VaPro Plus Pocket, VaPro Plus | Hollister Incorporated | 2019-12-13 |
| K192468 | 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... | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 |
| K191633 | Infyna Chic | Hollister Incorporated | 2019-07-19 |
| K190620 | SpeediCath Flex Coude Pro | Coloplast | 2019-07-10 |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Medline Industries, Inc. | 2019-06-12 |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-08 |
| K182511 | SimplCath | F&S Medical Solutions, LLC | 2019-03-20 |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Hollister Incorporated | 2018-12-18 |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | 2018-11-05 |
| K180258 | SpeediCath Standard | Coloplast | 2018-10-25 |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018-08-16 |
| K180824 | VaPro 2 Intermittent Catheter | Hollister Incorporated | 2018-06-22 |
| K180070 | SpeediCath Flex Coude Pro | Coloplast | 2018-02-02 |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | Cook Incorporated | 2017-11-22 |
| K163179 | Onli Intermittent Catheter | Hollister Incorporated | 2017-01-26 |
| K161672 | SpeediCath Flex Coude | Coloplast Corp. | 2016-09-29 |
| K160795 | United Urologics Intermittent Catheter | Robling Medical | 2016-06-16 |
| K151772 | Actreen Mini Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2016-02-09 |
| K152268 | VAPRO PLUS POCKET Intermittent Catheter | Hollister Incorporated | 2015-09-09 |
| K150935 | SpeediCath Compact Eve | Coloplast A/S | 2015-07-02 |
| K142767 | ThinkMed Intermittent Catheter with/without Hydrophilic Coating | Thinkmed Medical Technology Co., Ltd. | 2015-02-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| H67141965070 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2022-05-25 |
| H67141965050 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2022-05-25 |
| 09350902001225 | O'Neil Intermittent Urinary Catheter | GO MEDICAL INDUSTRIES PTY. LTD. | 2017-05-17 |
| 09350902001201 | O'Neil Intermittent Urinary Catheter | GO MEDICAL INDUSTRIES PTY. LTD. | 2017-05-17 |
| 09350902001188 | O'Neil Intermittent Urinary Catheter | GO MEDICAL INDUSTRIES PTY. LTD. | 2017-05-17 |
| 09350902001140 | O'Neil Intermittent Urinary Catheter | GO MEDICAL INDUSTRIES PTY. LTD. | 2017-05-17 |
| 08714729005179 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751557 | Open End Ureteral Axxcess Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729700517 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729012900 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729012887 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729005162 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729005193 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729011071 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729011088 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729011231 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729011248 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729011255 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729011316 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729012894 | Ureteral Catheter | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| H67141935090 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141950050 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141950070 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141950090 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141935070 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141935050 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141980050 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141980070 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141980090 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141900010 | URI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |