The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Verastep.
| Device ID | K012539 |
| 510k Number | K012539 |
| Device Name: | VERASTEP |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2001-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521093614 | K012539 | 000 |
| 10884521078550 | K012539 | 000 |
| 20884521084206 | K012539 | 000 |
| 20884521084183 | K012539 | 000 |
| 20884521084176 | K012539 | 000 |
| 10884521081048 | K012539 | 000 |
| 20884521082882 | K012539 | 000 |
| 20884521082875 | K012539 | 000 |
| 20884521082851 | K012539 | 000 |
| 20884521082844 | K012539 | 000 |
| 20884521082820 | K012539 | 000 |
| 20884521082813 | K012539 | 000 |
| 10884521078567 | K012539 | 000 |
| 10884521080966 | K012539 | 000 |
| 10884521080928 | K012539 | 000 |
| 10884521078598 | K012539 | 000 |
| 10884521081024 | K012539 | 000 |
| 10884521078574 | K012539 | 000 |
| 10884521078581 | K012539 | 000 |
| 10884521080935 | K012539 | 000 |
| 10884521093607 | K012539 | 000 |
| 10884521084193 | K012539 | 000 |
| 10884521084162 | K012539 | 000 |
| 10884521084155 | K012539 | 000 |
| 10884521084148 | K012539 | 000 |
| 10884521084131 | K012539 | 000 |
| 10884521084117 | K012539 | 000 |
| 10884521082861 | K012539 | 000 |
| 10884521082830 | K012539 | 000 |
| 20884521082806 | K012539 | 000 |
| 10884521081062 | K012539 | 000 |
| 10884521081055 | K012539 | 000 |
| 10884521081031 | K012539 | 000 |
| 10884521081000 | K012539 | 000 |
| 10884521080980 | K012539 | 000 |
| 10884521080959 | K012539 | 000 |
| 10884521081017 | K012539 | 000 |