510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123864Substantially Equivalent

Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam Sb 3 Capsule Endoscopy System

Given Imaging Ltd., Yokneam (P.O.Box 258), IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123864 is the FDA 510(k) clearance record for GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM, a class II device, cleared for Given Imaging , Ltd. on under FDA product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule). FDA records list 30 510(k) clearances for Given Imaging , Ltd., from to . As of , FDA records show no recalls naming K123864.

Clearance record

Decision date
Received
(238 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
Given Imaging , Ltd. Shaar Yokneam (Hermon Bldg., Yokneam (P.O.Box 258), IL
510(k) summary
Summary PDF
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