Olympus Surgical Technologies America
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE L | August 23, 2024 |
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | September 27, 2021 |
| K193517 | ViziShot 2 FLEX | March 18, 2020 |
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELa | August 9, 2019 |
| K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | April 4, 2019 |
| K181193 | PeriView FLEX | July 3, 2018 |
| K171232 | PeriView FLEX | September 21, 2017 |
| K163469 | ViziShot 2 FLEX | April 6, 2017 |
| K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter | March 27, 2015 |
| K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | October 21, 2013 |
| K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | February 4, 2013 |
| K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE | December 14, 2012 |