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
FDA 510(k) clearance K192468 · decided 2019-11-27
Clearance details
- K-number
- K192468
- Device name
- 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
- Applicant
- Hangzhou Bever Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-09
- Decision date
- 2019-11-27
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- GBM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| LotusCatheter (Lotus No Balloon Catheter) (K191512) | Hakki Medical Technologies, Inc. | 2020-05-21 |
| Actreen Hi-Lite Intermittent Urinary Catheters (K192577) | B.Braun Medical, Inc. | 2020-05-07 |
| VaPro Plus Pocket, VaPro Plus (K193148) | Hollister Incorporated | 2019-12-13 |
| Infyna Chic (K191633) | Hollister Incorporated | 2019-07-19 |
| SpeediCath Flex Coude Pro (K190620) | Coloplast | 2019-07-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU1 recall (Z-1061-2026) | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | 2026-01-12 |