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510(k) K080613

CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 by Minimally Invasive Devices, LLC — Product Code OCT

K080613 is an FDA 510(k) premarket notification submitted by Minimally Invasive Devices, LLC for the device "CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045". The FDA issued a decision of Substantially Equivalent on November 6, 2008. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. Minimally Invasive Devices, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2008
Date Received
March 4, 2008
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 by Minimally Invasive Devices, LLC

  • K150705 — FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm En (April 13, 2015)
  • K102452 — DEFOGGING AND CLEANING SOLUTION- FLO-X (December 23, 2010)

Other clearances for product code OCT

  • K251068 — KnoxFog Anti-fogging Device (August 27, 2025)
  • K231822 — GOLFF Sterile Anti-Fog Solution (February 26, 2024)
  • K221293 — E-Brik Visualization Assistant (July 7, 2022)
  • 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)

FDA data resources