LotusCatheter (Lotus No Balloon Catheter)
FDA 510(k) clearance K191512 · decided 2020-05-21
Clearance details
- K-number
- K191512
- Device name
- LotusCatheter (Lotus No Balloon Catheter)
- Applicant
- Hakki Medical Technologies, Inc.
- Decision
- Unknown
- Date received
- 2019-06-07
- Decision date
- 2020-05-21
- Days to decision
- 349 days
- Clearance type
- Traditional
- Product code
- GBM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (K241734) | Well Lead Medical Co., Ltd. | 2025-03-05 |
| GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (K213283) | Convatec Limited | 2022-06-22 |
| Intermittent Catheter (Not Finalized) (K211436) | Hollister Incorporated | 2022-01-27 |
| SpeediCath Compact Set (K200820) | Coloplast | 2020-11-13 |
| SpeediCath Compact Set (K192904) | Coloplast | 2020-11-02 |
| SpeediCath Soft (K200142) | Coloplast | 2020-07-30 |
| Jimushi Sterile Urethral Catheter for single use (K200134) | Hangzhou Jimushi Meditech Co., Ltd. | 2020-06-01 |
| 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 |
| 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 (K192468) | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 |
| Infyna Chic (K191633) | Hollister Incorporated | 2019-07-19 |
| SpeediCath Flex Coude Pro (K190620) | Coloplast | 2019-07-10 |
Recalls involving this device
No recalls on record reference this clearance.