Konix Anti-Fog Solution
FDA 510(k) clearance K190864 · decided 2020-08-27
Clearance details
- K-number
- K190864
- Device name
- Konix Anti-Fog Solution
- Applicant
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
- Decision
- Substantially Equivalent
- Date received
- 2019-04-03
- Decision date
- 2020-08-27
- Days to decision
- 512 days
- Clearance type
- Traditional
- Product code
- OCT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Istanbul, TR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KnoxFog Anti-fogging Device (K251068) | Uv One Hygienics, Inc. | 2025-08-27 |
| GOLFF Sterile Anti-Fog Solution (K231822) | Batrik Medical Manufacturing, Inc. | 2024-02-26 |
| E-Brik Visualization Assistant (K221293) | Jdi Surgical, Inc. | 2022-07-07 |
| AMD Anti-Fog Solution (K181887) | Advanced Medical Design Co., Ltd. | 2019-01-22 |
| VitreOx Anti-fog Solution (K163257) | Sio2 Nanotech, LLC | 2017-05-24 |
| Medline Anti-Fog Solution (K152948) | Medline Industries, Inc. | 2016-02-04 |
| LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (K120821) | Misder, LLC | 2012-05-11 |
| UNIMAX ANTI-FOG SOLUTION (K111622) | Unimax Medical Systems, Inc. | 2011-09-09 |
| DEFOGGING AND CLEANING SOLUTION- FLO-X (K102452) | Minimally Invasive Devices, LLC | 2010-12-23 |
| CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 (K080613) | Minimally Invasive Devices, LLC | 2008-11-06 |
| XODUS MEDICAL ANTI-FOG SOLUTION (K063587) | Xodus Medical, Inc. | 2007-01-09 |
| ORS MODEL 6000 ENDOSCOPE HOLDER (K051979) | O.R. Solutions, Inc. | 2005-08-30 |
Recalls involving this device
No recalls on record reference this clearance.