510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080613Substantially Equivalent

Clear-Vu System, Models: Cvl-01-1000, Cvl-01-1030, Cvl-01-1045

Minimally Invasive Devices, LLC, Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080613 is the FDA 510(k) clearance record for CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045, a class II device, cleared for Minimally Invasive Devices, LLC on under FDA product code OCT (Anti Fog Solution And Accessories, Endoscopy). FDA's definition for product code OCT reads: "To prevent, reduce or eliminate condensation (fog) on endoscopic lens". FDA records list 3 510(k) clearances for Minimally Invasive Devices, LLC, from to . As of , FDA records show no recalls naming K080613.

Clearance record

Decision date
Received
(247 days to decision)
Product code
OCT Anti Fog Solution And Accessories, Endoscopy
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Minimally Invasive Devices, LLC 1035 Waldo Way, Twinsburg OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCT

Trailing 12 months

FDA records hold no clearances under product code OCT in the trailing twelve months.

FDA records show no clearances under product code OCT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260