K233471 is an FDA 510(k) clearance for the Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136), a Single-use Reprocessed Ultrasonic Surgical Instruments, submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on February 20, 2024, 118 days after receiving the submission on October 25, 2023. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K233471 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 2023 |
| Decision Date | February 20, 2024 |
| Days to Decision | 118 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). |