Cleared Traditional

K211684 - PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211684 · Given Imaging Ltd. (Medtronic) · Gastroenterology & Urology device
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Aug 2021
Decision
87d
Days
Class 2
Risk

K211684 is an FDA 510(k) clearance for the PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Given Imaging Ltd. (Medtronic) (Yoqneam Northern, IL). The FDA issued a Cleared decision on August 27, 2021 after a review of 87 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. (Medtronic) devices

Submission Details

510(k) Number K211684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2021
Decision Date August 27, 2021
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Hogan Lovells US LLP
Randy J. Prebula

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 45
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