K202554 is an FDA 510(k) clearance for the Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis. This device is classified as a Single-use Reprocessed Ultrasonic Surgical Instruments.
Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on March 16, 2021, 194 days after receiving the submission on September 3, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Single-use Reprocessed Versions Of The Ultrasonic Devices Used In Surgical Procedures Either For Fragmentation, Emulsification And Aspiration Of Soft Tissue And Hard Tissue Or For Ligation Of Vessels (under Product Code ?lfl?). Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission.. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K202554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2020 |
| Decision Date | March 16, 2021 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NLQ — Single-use Reprocessed Ultrasonic Surgical Instruments |
| Device Class | — |
| Definition | Single-use Reprocessed Versions Of The Ultrasonic Devices Used In Surgical Procedures Either For Fragmentation, Emulsification And Aspiration Of Soft Tissue And Hard Tissue Or For Ligation Of Vessels (under Product Code ?lfl?). Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission.. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |