The following data is part of a premarket notification filed by Microaire Surgical Instruments Llc with the FDA for Smartrelease Endoscopic Soft Tissue Release System.
| Device ID | K181819 |
| 510k Number | K181819 |
| Device Name: | SMARTRELEASE Endoscopic Soft Tissue Release System |
| Classification | Arthroscope |
| Applicant | MicroAire Surgical Instruments LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 |
| Contact | Glenn Gerstenfeld |
| Correspondent | Vikki M. O'connor Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, FL 32043 |
| 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 | 2018-07-09 |
| Decision Date | 2018-11-06 |
| Summary: | summary |