The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Endoscopic Trocars And Cannulas.
| Device ID | K063788 |
| 510k Number | K063788 |
| Device Name: | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Katie Bray |
| Correspondent | Katie Bray 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 | 2006-12-21 |
| Decision Date | 2007-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825017102 | K063788 | 000 |
| 30885825016587 | K063788 | 000 |
| 30885825016570 | K063788 | 000 |
| 30885825016549 | K063788 | 000 |
| 30885825016532 | K063788 | 000 |
| 30885825016396 | K063788 | 000 |
| 30885825016372 | K063788 | 000 |
| 30885825016365 | K063788 | 000 |
| 30885825014507 | K063788 | 000 |
| 30885825014187 | K063788 | 000 |
| 30885825016617 | K063788 | 000 |
| 30885825016648 | K063788 | 000 |
| 30885825017096 | K063788 | 000 |
| 30885825017089 | K063788 | 000 |
| 30885825016822 | K063788 | 000 |
| 30885825016815 | K063788 | 000 |
| 30885825016808 | K063788 | 000 |
| 30885825016792 | K063788 | 000 |
| 30885825016785 | K063788 | 000 |
| 30885825016778 | K063788 | 000 |
| 30885825016655 | K063788 | 000 |
| 30885825012657 | K063788 | 000 |