Cleared Traditional

K170839 - RAPID Web

K170839 is an FDA 510(k) clearance for RAPID Web, 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 66-day FDA review.

K170839 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
66d
Days
Class 2
Risk

K170839 is an FDA 510(k) clearance for the RAPID Web. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Yoqneam, IL). The FDA issued a Cleared decision on May 26, 2017 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Given Imaging , Ltd. devices

FDA 510(k) Submission Details - K170839

510(k) Number K170839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2017
Decision Date May 26, 2017
Days to Decision 66 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
65d faster than avg
Panel avg: 131d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

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 K170839.
Olympus Small Intestinal Capsule Endoscope System
K173459 · Olympus Medical Systems Corp. · Mar 2018
MiroCam Capsule Endoscope System
K170438 · Intromedic Co., Ltd. · Jan 2018
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
K170210 · Given Imaging , Ltd. · Sep 2017
AdvanCE capsule endoscope delivery device
K163495 · United States Endoscopy Group, Inc. · Mar 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069 · Olympus Medical Systems Corp. · Jan 2017
CapsoCam Plus (SV-3) Capsule Endoscope System
K161773 · CapsoVision, Inc. · Oct 2016