510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K090557Substantially Equivalent

Given Pillcam Platform Will Pillcam Sb Capsules, Eso Capsules, Given Agile Patency System

Given Imaging Ltd., Yoqneaam, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090557 is the FDA 510(k) clearance record for GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM, a class II device, cleared for Given Imaging , Ltd. on under FDA product code NSI (System, Imaging, Esophageal, Wireless, Capsule). FDA's definition for product code NSI reads: "THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING...". FDA records list 30 510(k) clearances for Given Imaging , Ltd., from to . As of , FDA records show no recalls naming K090557.

Clearance record

Decision date
Received
(210 days to decision)
Product code
NSI System, Imaging, Esophageal, Wireless, Capsule
Regulation
21 CFR 876.1300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Given Imaging , Ltd. New Industrial Park, Yoqneaam, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NSI

Trailing 12 months

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

FDA records show no clearances under product code NSI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NSI, 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