K170955 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector. This device is classified as a Single-use Reprocessed Ultrasonic Surgical Instruments.
Submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren (Redmond, US). The FDA issued a Cleared decision on July 3, 2017, 94 days after receiving the submission on March 31, 2017.
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 | K170955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2017 |
| Decision Date | July 03, 2017 |
| Days to Decision | 94 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). |