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PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

by Given Imaging Ltd. (Medtronic) 2 variants

510(k) K230991

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK230991 Date30 Jun 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NEZ
Device Class
Class II
Regulation
21 CFR Part 876.1300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PillCam SB 3 capsule endoscopy system is a wireless, ingestible capsule endoscopy system designed for visualization of the small bowel. It is classified as a Class II medical device under regulation number 876.1300 and is substantially equivalent to a predicate device.

The system is supplied as a single-use ingestible capsule and is used in a clinic or hospital environment administered by a clinician or staff. It includes PillCam Software 9.0E for image processing and is authorized under FDA 510(k) clearance K230991.

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