K181819 is an FDA 510(k) clearance for the SMARTRELEASE Endoscopic Soft Tissue Release System. This device is classified as a Arthroscope (Class II - Special Controls, product code HRX).
Submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on November 6, 2018, 120 days after receiving the submission on July 9, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 888.1100. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K181819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2018 |
| Decision Date | November 06, 2018 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | HRX - Arthroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.1100 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |