K150524 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology. This device is classified as a Single-use Reprocessed Ultrasonic Surgical Instruments.
Submitted by Surgical Instrument Services and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on December 16, 2015, 289 days after receiving the submission on March 2, 2015.
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 | K150524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2015 |
| Decision Date | December 16, 2015 |
| Days to Decision | 289 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). |