← Back to catalogue

Given Pillcam Platform With Pillcam Sb Capsules

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101250

by Given Imaging , Ltd.

Identifiers

510(k) Number
K101250 FDA 510(k)
FDA Product Code
NEZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1300 FDA 510(k)
Regulation Number
876.1300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Given Pillcam Platform With Pillcam Sb Capsules is a wireless capsule endoscopy system used for imaging the gastrointestinal tract. It is classified as a Class II medical device under regulation number 876.1300 and is substantially equivalent to a predicate device as determined by FDA 510(k) clearance K101250.

The device is supplied by Given Imaging, Ltd., located in Yoqneaam, Israel, and is authorized for use in gastroenterology and urology applications. It is a single-use, non-sterile imaging capsule system intended for visualizing the small bowel and other GI regions, with no claims regarding MRI safety or reusability stated in the provided data.

Frequently asked questions

What is the Given Pillcam Platform With Pillcam Sb Capsules used for?

The Given Pillcam Platform With Pillcam Sb Capsules is a wireless capsule endoscopy system used for imaging the gastrointestinal tract, specifically intended for visualizing the small bowel and other GI regions in gastroenterology and urology applications, as stated in the device description.

Is the Given Pillcam Platform With Pillcam Sb Capsules sterile or non-sterile, and is it reusable?

The device is supplied as a non-sterile imaging capsule system and is intended for single-use only, with no claims regarding reusability made in the provided data, meaning it should not be reused after initial patient use.

How is the Given Pillcam Platform With Pillcam Sb Capsules supplied and by whom?

The device is supplied by Given Imaging, Ltd., located in Yoqneaam, Israel, as a wireless capsule endoscopy system comprising the Pillcam platform and Pillcam SB capsules, intended for clinical use in gastrointestinal imaging.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Capsule Endoscopy Products - Medtronic, Given Imaging PillCam Capsule Endoscopy : User's Manual, 510(k) Premarket Notification - Food and Drug Administration, PDF PillCam capsule endoscopy platform - Medtronic

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Given Imaging , Ltd.

Sources (1)

  • FDA 510(k) K101250 24 fields · synced Sep 22, 2026