The following data is part of a premarket notification filed by Venclose, Inc. with the FDA for Venclose Radiofrequency System (digirf Generator, Evsrf Catheter).
| Device ID | K160754 |
| 510k Number | K160754 |
| Device Name: | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VENCLOSE, INC. 2570 N. 1ST., 2ND FL #221 San Jose, CA 95131 |
| Contact | Mai Ly Wilcox |
| Correspondent | Pamela M. Buckman PAMELA M. BUCKMAN, MSN 2800 PLEASANT HILL RD. #175 Pleasant Hill, CA 94523 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2016-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858254006190 | K160754 | 000 |
| 00858254006084 | K160754 | 000 |
| 00858254006077 | K160754 | 000 |
| 00858254006060 | K160754 | 000 |
| 00858254006053 | K160754 | 000 |
| 00858254006046 | K160754 | 000 |
| 00858254006022 | K160754 | 000 |
| 00858254006015 | K160754 | 000 |
| 00858254006008 | K160754 | 000 |
| 00858254006091 | K160754 | 000 |
| 00858254006107 | K160754 | 000 |
| 00858254006183 | K160754 | 000 |
| 00858254006176 | K160754 | 000 |
| 00858254006169 | K160754 | 000 |
| 00858254006152 | K160754 | 000 |
| 00858254006145 | K160754 | 000 |
| 00858254006138 | K160754 | 000 |
| 00858254006121 | K160754 | 000 |
| 00858254006114 | K160754 | 000 |
| 00858254006039 | K160754 | 000 |