Bi-Flex Evo
FDA 510(k) clearance K182144 · decided 2018-09-07
Clearance details
- K-number
- K182144
- Device name
- Bi-Flex Evo
- Applicant
- Promepla Sam
- Decision
- Substantially Equivalent
- Date received
- 2018-08-08
- Decision date
- 2018-09-07
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KNY
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Monaco, MC
- 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 |
|---|---|---|
| Transurethral Catheter Safety Valve (TUCSV) (80050) (K260919) | Class Medical , Ltd. | 2026-08-05 |
| Vesair Cystoscopic Sheath (K162356) | Solace Therapeutics | 2017-03-02 |
| BI-FLEX URETERAL ACCESS SHEATH (K140441) | Promepla Sam | 2014-06-17 |
| WIJAY EZ-VOID EXTERNAL CATHETER VALVE (K140562) | Leomed, LLC | 2014-06-16 |
| GUARDIAN URETHRAL SHEATH (K141252) | Solace Therapeutics | 2014-06-09 |
| GUARDIAN URETHRAL SHEATH (K131803) | Solace Therapeutics | 2013-08-20 |
| VARI-PASS VARIABLE LENGTH ACCESS SHEATH (K123170) | Olympus Surgical Technologies America | 2013-02-04 |
| ROCAMED ROCAUS PLATINUM (K120160) | Promepla Sam | 2012-05-14 |
| PREFILLED CATHETER INFLATION SYRINGE (K112209) | Avail Medical Products, Inc. | 2011-09-08 |
| PRE-FILLED CATHETER INFLATION SYRINGE (K090121) | Avail Medical Products, Inc. | 2009-04-15 |
| CYSTOGLIDE INTRODUCER SHEATH (K052298) | Percutaneous Systems, Incorporated | 2006-12-12 |
| CAREVENT (K062240) | Chief Medical, LLC | 2006-10-16 |
Recalls involving this device
No recalls on record reference this clearance.