OCT — Anti Fog Solution And Accessories, Endoscopy Class II
FDA product code OCT covers "Anti Fog Solution And Accessories, Endoscopy", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OCT
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251068 | uv one hygienics | KnoxFog Anti-fogging Device | August 27, 2025 |
| K231822 | batrik medical manufacturing | GOLFF Sterile Anti-Fog Solution | February 26, 2024 |
| K221293 | jdi surgical | E-Brik Visualization Assistant | July 7, 2022 |
| K190864 | turkuaz saglik hizmetleri medikal temizlik kimyasal urunler | Konix Anti-Fog Solution | August 27, 2020 |
| K181887 | advanced medical design co | AMD Anti-Fog Solution | January 22, 2019 |
| K163257 | sio2 nanotech | VitreOx Anti-fog Solution | May 24, 2017 |
| K152948 | medline industries | Medline Anti-Fog Solution | February 4, 2016 |
| K120821 | misder | LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM | May 11, 2012 |
| K111622 | unimax medical systems | UNIMAX ANTI-FOG SOLUTION | September 9, 2011 |
| K102452 | minimally invasive devices | DEFOGGING AND CLEANING SOLUTION- FLO-X | December 23, 2010 |
| K080613 | minimally invasive devices | CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 | November 6, 2008 |
| K063587 | xodus medical | XODUS MEDICAL ANTI-FOG SOLUTION | January 9, 2007 |
| K051979 | o.r. solutions | ORS MODEL 6000 ENDOSCOPE HOLDER | August 30, 2005 |
| K022826 | preservation solutions | CLEAR-IT ANTI-FOG, MODEL PS003 | October 9, 2002 |
| K993604 | mectra labs | ENDOSCOPIC ANTI FOG DEVICE | March 3, 2000 |
| K982465 | deroyal industries | DEROYAL INDUSTRIES, INC. DEFOGGER | August 11, 1998 |
| K974454 | tucson medical | CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 | December 18, 1997 |
| K945732 | tonn chemical co | FOG FREE | January 4, 1995 |
| K942576 | white knight healthcare | CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE | July 5, 1994 |
| K923843 | sorex medical | FOGLESS | March 25, 1994 |