The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Tyco Healthcar with the FDA for Versaport Bladeless Low Profile Trocar Model Nb3shflp, Nb5shflp, Nb5stflp.
| Device ID | K100548 |
| 510k Number | K100548 |
| Device Name: | VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Angela Van Arsdale |
| Correspondent | Angela Van Arsdale COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-26 |
| Decision Date | 2010-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521076744 | K100548 | 000 |
| 20884521076737 | K100548 | 000 |
| 20884521076720 | K100548 | 000 |
| 20884521073514 | K100548 | 000 |
| 20884521073507 | K100548 | 000 |
| 20884521070469 | K100548 | 000 |
| 20884521070438 | K100548 | 000 |
| 20884521070391 | K100548 | 000 |