Home / 510(k) Clearances / K221293

510(k) K221293

E-Brik Visualization Assistant by Jdi Surgical, Inc. — Product Code OCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2022
Date Received
May 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Other clearances for product code OCT

  • K251068 — KnoxFog Anti-fogging Device (August 27, 2025)
  • K231822 — GOLFF Sterile Anti-Fog Solution (February 26, 2024)
  • K190864 — Konix Anti-Fog Solution (August 27, 2020)
  • K181887 — AMD Anti-Fog Solution (January 22, 2019)
  • K163257 — VitreOx Anti-fog Solution (May 24, 2017)
  • K152948 — Medline Anti-Fog Solution (February 4, 2016)
  • K120821 — LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (May 11, 2012)
  • K111622 — UNIMAX ANTI-FOG SOLUTION (September 9, 2011)
  • K102452 — DEFOGGING AND CLEANING SOLUTION- FLO-X (December 23, 2010)
  • K080613 — CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 (November 6, 2008)