E-Brik Visualization Assistant
FDA 510(k) K221293 · Jdi Surgical, Inc.
510(k) numberK221293
Submission
- Device name
- E-Brik Visualization Assistant
- Applicant
- Jdi Surgical, Inc.
Highlands Ranch, CO, US - Received
- May 4, 2022
- Decision date
- July 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCT – Anti Fog Solution And Accessories, Endoscopy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Other 510(k)s with product code OCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251068 | KnoxFog Anti-fogging DeviceOCT · Traditional | Uv One Hygienics, Inc. | 08/27/2025SE |
| K231822 | GOLFF Sterile Anti-Fog SolutionOCT · Traditional | Batrik Medical Manufacturing, Inc. | 02/26/2024SE |
| K190864 | Konix Anti-Fog SolutionOCT · Traditional | Turkuaz Saglik Hizmetleri Medikal Temizlik… | 08/27/2020SE |
| K181887 | AMD Anti-Fog SolutionOCT · Traditional | Advanced Medical Design Co., Ltd. | 01/22/2019SE |
| K163257 | VitreOx Anti-fog SolutionOCT · Traditional | Sio2 Nanotech, LLC | 05/24/2017SE |
| K152948 | Medline Anti-Fog SolutionOCT · Traditional | Medline Industries, Inc. | 02/04/2016SE |
| K120821 | Llics(Tm) Laparascopic Lens Internal Cleaning SystemOCT · Traditional | Misder, LLC | 05/11/2012SE |
| K111622 | Unimax Anti-Fog SolutionOCT · Traditional | Unimax Medical Systems, Inc. | 09/09/2011SE |
| K102452 | Defogging and Cleaning Solution- Flo-XOCT · Traditional | Minimally Invasive Devices, LLC | 12/23/2010SE |
| K080613 | Clear-Vu System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045OCT · Traditional | Minimally Invasive Devices, LLC | 11/06/2008SE |
Questions and answers
When was E-Brik Visualization Assistant cleared by the FDA?
E-Brik Visualization Assistant (K221293) received a 510(k) decision of Substantially Equivalent on July 7, 2022, 64 days after the submission was received.
What is the product code of K221293?
The FDA product code is OCT – Anti Fog Solution And Accessories, Endoscopy, a Class II (moderate risk) device regulated under 21 CFR 876.1500.