Company · US
Olympus Surgical Technologies America
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 |
| KTI | Bronchoscope Accessory | 4 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
| ODC | Endoscope Channel Accessory | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K262877 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America | GEX |
| Jul 24, 2026 | K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America | GEX |
| Aug 23, 2024 | K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America | GEX |
| Sep 27, 2021 | K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action Olympus Surgical Technologies America | GEI |
| Mar 18, 2020 | K193517 | ViziShot 2 FLEX Olympus Surgical Technologies America | KTI |
| Aug 9, 2019 | K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Acce Olympus Surgical Technologies America | GEX |
| Apr 4, 2019 | K190164 | CleverLock Guidewire Locking Device and Biopsy Cap Olympus Surgical Technologies America | ODC |
| Jul 3, 2018 | K181193 | PeriView FLEX Olympus Surgical Technologies America | KTI |
| Sep 21, 2017 | K171232 | PeriView FLEX Olympus Surgical Technologies America | KTI |
| Apr 6, 2017 | K163469 | ViziShot 2 FLEX Olympus Surgical Technologies America | KTI |
| Mar 27, 2015 | K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter Olympus Surgical Technologies America | FGE |
| Oct 21, 2013 | K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER Olympus Surgical Technologies America | EZN |
| Feb 4, 2013 | K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH Olympus Surgical Technologies America | KNY |
| Dec 14, 2012 | K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE Olympus Surgical Technologies America | KNS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||