510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K000252Substantially Equivalent

Insight 4000 Endoscope

Insight Instruments Mfg., Inc., Sanford FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000252 is the FDA 510(k) clearance record for INSIGHT 4000 ENDOSCOPE, a class II device, cleared for Insight Instruments Mfg., Inc. on under FDA product code MPA (Endoilluminator). FDA records list one 510(k) clearance for Insight Instruments Mfg., Inc. As of , FDA records show no recalls naming K000252.

Clearance record

Decision date
Received
(264 days to decision)
Product code
MPA Endoilluminator
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Insight Instruments Mfg., Inc. 5400 S. Bryant Ave., Sanford FL
510(k) summary
Statement
Third party review
No

Clearances, product code MPA

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