510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120023Unknown

Given Pillcam Colon 2 Capsule Endoscopy System

Given Imaging Ltd., Yoqneam, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN120023 is the FDA 510(k) clearance record for GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM, a class II device, cleared for Given Imaging , Ltd. on under FDA product code PGD (Colon Capsule Imaging System). FDA's definition for product code PGD reads: "visualization of the colon for the detection of polyps". FDA records list 30 510(k) clearances for Given Imaging , Ltd., from to . As of , FDA records show no recalls naming DEN120023.

Clearance record

Decision date
Received
(426 days to decision)
Product code
PGD Colon Capsule Imaging System
Regulation
21 CFR 876.1330
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Given Imaging , Ltd. Hermon Bldg., New Industrial Park, P.O. Box 258, Yoqneam, IL
Third party review
No

Clearances, product code PGD

Trailing 12 months

FDA records hold no clearances under product code PGD in the trailing twelve months.

FDA records show no clearances under product code PGD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PGD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260