The following data is part of a premarket notification filed by Promepla Sam with the FDA for Bi-flex Ureteral Access Sheath.
| Device ID | K140441 |
| 510k Number | K140441 |
| Device Name: | BI-FLEX URETERAL ACCESS SHEATH |
| Classification | Accessories, Catheter, G-u |
| Applicant | PROMEPLA SAM LE COPORI-9 AVENUE PRINCE ALBERT II Monaco, MC Mc 9800 |
| Contact | Mohamed Rekik |
| Correspondent | Mohamed Rekik PROMEPLA SAM LE COPORI-9 AVENUE PRINCE ALBERT II Monaco, MC Mc 9800 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700512986225 | K140441 | 000 |
| 03700512983590 | K140441 | 000 |
| 03700512983606 | K140441 | 000 |
| 03700512983613 | K140441 | 000 |
| 03700512985587 | K140441 | 000 |
| 03700512985594 | K140441 | 000 |
| 03700512985600 | K140441 | 000 |
| 03700512985617 | K140441 | 000 |
| 03700512986195 | K140441 | 000 |
| 03700512986201 | K140441 | 000 |
| 03700512986218 | K140441 | 000 |
| 03700512963585 | K140441 | 000 |