The following data is part of a premarket notification filed by Vectec with the FDA for Vectec Disposable Trocars And Laparoscopic Accessories.
| Device ID | K071976 |
| 510k Number | K071976 |
| Device Name: | VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VECTEC 1220 NINETEENTH STREET; N.W. SUITE 300 Washington, DC 20036 |
| Contact | Diane M Horwitz |
| Correspondent | Diane M Horwitz VECTEC 1220 NINETEENTH STREET; N.W. SUITE 300 Washington, DC 20036 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-17 |
| Decision Date | 2007-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700393301513 | K071976 | 000 |
| 03700393300196 | K071976 | 000 |
| 03700393300172 | K071976 | 000 |
| 03700393300158 | K071976 | 000 |
| 03700393300608 | K071976 | 000 |
| 03700393300585 | K071976 | 000 |
| 03700393300561 | K071976 | 000 |
| 03700393300547 | K071976 | 000 |
| 03700393300059 | K071976 | 000 |
| 03700393300219 | K071976 | 000 |
| 03700393300233 | K071976 | 000 |
| 03700393301438 | K071976 | 000 |
| 03700393301032 | K071976 | 000 |
| 03700393300844 | K071976 | 000 |
| 03700393300776 | K071976 | 000 |
| 03700393300455 | K071976 | 000 |
| 03700393300493 | K071976 | 000 |
| 03700393300295 | K071976 | 000 |
| 03700393300257 | K071976 | 000 |
| 03700393300516 | K071976 | 000 |