510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K190512Substantially Equivalent

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare

Intelligent Endoscopy, Clemmons NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190512 is the FDA 510(k) clearance record for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare, a class II device, cleared for Intelligent Endoscopy on under FDA product code FDI (Snare, Flexible). FDA records list one 510(k) clearance for Intelligent Endoscopy. As of , FDA records show no recalls naming K190512.

Clearance record

Decision date
Received
(266 days to decision)
Product code
FDI Snare, Flexible
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Intelligent Endoscopy 4740 Commercial Park Ct., Suite 1, Clemmons NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDI

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