The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Trocars.
| Device ID | K062497 |
| 510k Number | K062497 |
| Device Name: | REPROCESSED TROCARS |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Elizabeth Renkin |
| Correspondent | Elizabeth Renkin ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2007-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825020898 | K062497 | 000 |
| 30885825014262 | K062497 | 000 |
| 30885825014279 | K062497 | 000 |
| 30885825014439 | K062497 | 000 |
| 30885825014453 | K062497 | 000 |
| 30885825014538 | K062497 | 000 |
| 30885825015306 | K062497 | 000 |
| 30885825016556 | K062497 | 000 |
| 30885825016563 | K062497 | 000 |
| 30885825014255 | K062497 | 000 |