The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Non-telescopic Penevac.
| Device ID | K160160 |
| 510k Number | K160160 |
| Device Name: | Non-Telescopic PenEvac |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | I.C. Medical, Inc. 2340 W. Shangri La Rd. Phoenix, AZ 85029 |
| Contact | Elena S. Buiga |
| Correspondent | Elena S. Buiga I.C. Medical, Inc. 2340 W. Shangri La Rd. Phoenix, AZ 85029 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817688022442 | K160160 | 000 |
| 00817688020660 | K160160 | 000 |
| 00817688020646 | K160160 | 000 |
| 00817688021803 | K160160 | 000 |
| 00817688020615 | K160160 | 000 |
| 00817688020592 | K160160 | 000 |
| 00817688020578 | K160160 | 000 |
| 00817688020554 | K160160 | 000 |
| 00817688020530 | K160160 | 000 |
| 00817688020516 | K160160 | 000 |
| 00817688020493 | K160160 | 000 |
| 00817688020684 | K160160 | 000 |
| 00817688020707 | K160160 | 000 |
| 00817688022213 | K160160 | 000 |
| 00817688022190 | K160160 | 000 |
| 00817688022077 | K160160 | 000 |
| 00817688022060 | K160160 | 000 |
| 00817688022022 | K160160 | 000 |
| 00817688022008 | K160160 | 000 |
| 00817688020783 | K160160 | 000 |
| 00817688020752 | K160160 | 000 |
| 00817688020745 | K160160 | 000 |
| 00817688020721 | K160160 | 000 |
| 00817688020417 | K160160 | 000 |