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 | K202554 |
| 510k Number | K202554 |
| 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 | Aphrodeja Crutch |
| Correspondent | Aphrodeja Crutch 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 | 2020-09-03 |
| Decision Date | 2021-03-16 |
| Summary: | summary |