Brooklyn Park, MN, US · 7 510(k) clearances · 12 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 3 | 2026-03-02 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 2 | 2023-01-27 |
| FGB | — | — | — | 1 | 2024-03-25 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | Ear, Nose, Throat | 1 | 2022-01-19 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-05-07 | P180007-S015 | Spiration Valve System (SVS) | 30-Day Notice | NJK | Valve, Pulmonary | Unknown |
| 2024-08-16 | P180007-S013 | Spiration® Valve System | 30-Day Notice | NJK | Valve, Pulmonary | Unknown |
| 2024-06-27 | P180007-S012 | Spiration Valve System Deployment Catheter and Loader | 30-Day Notice | NJK | Valve, Pulmonary | Unknown |
| 2023-09-22 | P180007-S011 | Spiration Valve System | Normal 180 Day Track No User Fee | NJK | Valve, Pulmonary | Unknown |
| 2022-05-12 | P180007-S009 | SVS Deployment Catheter and Loader | 30-Day Notice | NJK | Valve, Pulmonary | Unknown |
| 2021-09-01 | P180007-S008 | Spiration Valve System | Normal 180 Day Track No User Fee | NJK | Valve, Pulmonary | Unknown |
| 2021-05-19 | P870076-S027 | Falope Ring Band and Applicator Systems | 30-Day Notice | KNH | Laparoscopic Contraceptive Tubal Occlusion Device | Obstetrics/Gynecology |
| 2021-05-11 | P870076-S026 | Falope-Ring® Band and Applicator Systems | Special (Immediate Track) | KNH | Laparoscopic Contraceptive Tubal Occlusion Device | Obstetrics/Gynecology |
| 2020-12-23 | P180007-S007 | Spiration® Valve System (SVS) | Normal 180 Day Track No User Fee | NJK | Valve, Pulmonary | Unknown |
| 2020-12-15 | P180007-S005 | Spiration® Valve System | Normal 180 Day Track | NJK | Valve, Pulmonary | Unknown |
| 2020-07-02 | P870076-S025 | Falope Ring Bands | 30-Day Notice | KNH | Laparoscopic Contraceptive Tubal Occlusion Device | Obstetrics/Gynecology |
| 2020-02-12 | P870076-S024 | Trocar Knife | 30-Day Notice | KNH | Laparoscopic Contraceptive Tubal Occlusion Device | Obstetrics/Gynecology |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-02 | K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | GEI | Class II | General, Plastic Surgery |
| 2024-03-25 | K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | FGB | — | — |
| 2023-10-25 | K231327 | POWERSEAL Sealer and Divider | GEI | Class II | General, Plastic Surgery |
| 2023-01-27 | K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | GEX | Class II | General, Plastic Surgery |
| 2022-01-19 | K212650 | Celeris, Disposable Sinus Debrider | ERL | Class II | Ear, Nose, Throat |
| 2022-01-04 | K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | GEI | Class II | General, Plastic Surgery |
| 2021-06-03 | K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | Class II | General, Plastic Surgery |