The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Dilating Tip Trocars.
| Device ID | K132629 |
| 510k Number | K132629 |
| Device Name: | REPROCESSED DILATING TIP TROCARS |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST DRAKE DRIVE Tempe, AZ 85283 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST DRAKE DRIVE Tempe, AZ 85283 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-22 |
| Decision Date | 2013-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825017287 | K132629 | 000 |
| 30885825017270 | K132629 | 000 |
| 30885825017263 | K132629 | 000 |
| 30885825017256 | K132629 | 000 |
| 30885825017249 | K132629 | 000 |
| 30885825017232 | K132629 | 000 |