510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261890Substantially Equivalent

52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®

Boehringer Laboratories, LLC, Phoenixville PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261890 is the FDA 510(k) clearance record for 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®, a class II device, cleared for Boehringer Laboratories, LLC on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 44 510(k) clearances for Boehringer Laboratories, LLC, from to . As of , FDA records show no recalls naming K261890.

Clearance record

Decision date
Received
(70 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boehringer Laboratories, LLC 300 Thoms Dr., Phoenixville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNT

Trailing 12 months
2 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260