510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163495Substantially Equivalent

AdvanCE capsule endoscope delivery device

United States Endoscopy Group, Inc., Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K163495 is the FDA 510(k) clearance record for AdvanCE capsule endoscope delivery device, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule). FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K163495.

Clearance record

Decision date
Received
(87 days to decision)
Product code
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation
21 CFR 876.1300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 5976 Heisley Rd., Mentor OH
510(k) summary
Statement
Third party review
No

Clearances, product code NEZ

Trailing 12 months
2 clearances under product code NEZ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NEZ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260