The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Harmonic Ace+7, 5 Mm Diameter Shears With Advanced Hemostasis.
| Device ID | K161693 |
| 510k Number | K161693 |
| Device Name: | Reprocessed HARMONIC ACE+7, 5 Mm Diameter Shears With Advanced Hemostasis |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS 1810 W. Drake Dr. Tempe, AZ 85283 |
| Contact | Scott English |
| Correspondent | Scott English STRYKER SUSTAINABILITY SOLUTIONS 1810 W. Drake Dr. Tempe, AZ 85283 |
| Product Code | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2017-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327346252 | K161693 | 000 |
| 37613327346245 | K161693 | 000 |
| 37613327346238 | K161693 | 000 |