K111794 is an FDA 510(k) clearance for the REPROCESSED HARMONIC SCALPEL. This device is classified as a Single-use Reprocessed Ultrasonic Surgical Instruments.
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on January 11, 2012, 198 days after receiving the submission on June 27, 2011.
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 | K111794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2011 |
| Decision Date | January 11, 2012 |
| Days to Decision | 198 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). |