Smoklean
FDA 510(k) clearance K173108 · decided 2018-05-18
Clearance details
- K-number
- K173108
- Device name
- Smoklean
- Applicant
- Sejong Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-29
- Decision date
- 2018-05-18
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- FYD
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Paju-Si, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sejong Medical Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PlumeSafe X5 Smoke Management System (K240127) | Conmed Corporation | 2024-08-05 |
| 8Q10 Surclear Smoke Plume Evacuation System (K233789) | Surnic Corporation | 2024-04-10 |
| Medline Smoke Evacuation Shroud (K213068) | Medline Industries, Inc. | 2022-01-03 |
| NEBULAE SRS Laparoscopic Surgical Smoke Removal System (K202944) | Northgate Technologies, Inc. | 2021-03-25 |
| Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor (K200250) | Megadyne Medical Products, Inc. | 2020-06-26 |
| EvaQMax Smoke Evacuation System (K192035) | Bio Protech, Inc. | 2019-08-29 |
| Megadyne Foot Switch (K191328) | Megadyne Medical Products, Inc. | 2019-07-26 |
| SafeAir Smoke Evacuator compact (K182224) | Lina Medical Aps | 2019-02-07 |
| Crystal Vision (K163659) | I.C Medical, Inc. | 2017-10-30 |
| RapidVac Smoke Evacuator System (K142335) | Covidien | 2015-01-14 |
| VISICLEAR SMOKE EVACUATION SYSTEM (K131402) | Buffalo Filter Co., Inc. | 2014-03-03 |
| CONMED AER DEFENSE SMOKE EVACUATOR (K091139) | Conmed Corporation | 2009-05-05 |
Recalls involving this device
No recalls on record reference this clearance.