Cleared Traditional

K101200 - PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE

K101200 is an FDA 510(k) clearance for PILLCAM EXPRESS VIDEO CAPSULES DELIVERY..., manufactured by Given Imaging , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code NEZ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K101200 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
154d
Days
Class 2
Risk

K101200 is an FDA 510(k) clearance for the PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Yokneam (P.O.Box 258), IL). The FDA issued a Cleared decision on September 30, 2010 after a review of 154 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Given Imaging , Ltd. devices

FDA 510(k) Submission Details - K101200

510(k) Number K101200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2010
Decision Date September 30, 2010
Days to Decision 154 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 131d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

NEZ Device Classification - Class 2, Special Controls

Product Code NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01088646 Completed Interventional Industry-sponsored

Evaluation of PillCam® Express Capsule Endoscopy Delivery System

25
Patients (actual)
3
Sites
Device_feasibility
Purpose
Single blind
Masking
Condition studied Small Bowel Disease; Inflammatory Bowel Disease
Study design Single group
Eligibility All sexes · 2 Years+
Principal investigator Jonathan Leighton, MD
Sponsor Medtronic - MITG (industry)
Started 2009-10-01 → Primary completion 2010-05-01
Primary outcome
Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
Secondary outcome
Physician's Subjective Assessment of the Ease of Capsule Placement
View full study on ClinicalTrials.gov

Regulatory Peers - NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

All 46
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K101200.
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
K103025 · Given Imaging , Ltd. · May 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
K101250 · Given Imaging , Ltd. · Mar 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
K103088 · Given Imaging , Ltd. · Jan 2011
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210 · Olympus Medical Systems Corporation · Jul 2009
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
K091405 · Given Imaging , Ltd. · Jul 2009
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K063259 · Olympus Medical Systems Corporation · Sep 2007