The following data is part of a premarket notification filed by Microaire Surgical Instruments with the FDA for Smartrelease Endoscopic Soft Tissue Release System.
| Device ID | K211297 |
| 510k Number | K211297 |
| Device Name: | SMARTRELEASE Endoscopic Soft Tissue Release System |
| Classification | Arthroscope |
| Applicant | MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Contact | Glenn Gerstenfeld |
| Correspondent | Glenn Gerstenfeld MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Product Code | HRX |
| Subsequent Product Code | EMF |
| Subsequent Product Code | KCT |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-28 |
| Decision Date | 2021-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399016942 | K211297 | 000 |
| 10847399017236 | K211297 | 000 |
| 10847399017243 | K211297 | 000 |
| 00847399016003 | K211297 | 000 |
| 00847399016010 | K211297 | 000 |
| 00847399016027 | K211297 | 000 |
| 00847399016034 | K211297 | 000 |
| 00847399016041 | K211297 | 000 |
| 00847399016928 | K211297 | 000 |
| 00847399016935 | K211297 | 000 |
| 00847399015907 | K211297 | 000 |