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FDA 510(k)

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

K-Number: K230991 · 2023-06-30

ApplicantGiven Imaging Ltd. (Medtronic)
Decision Date2023-06-30
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is a medical device manufactured by Given Imaging Ltd. (Medtronic). It received FDA 510(k) clearance on 2023-06-30 under approval number K230991. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Given Imaging Ltd. (Medtronic). The 510(k) number is K230991.

When was PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E approved by the FDA?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E received FDA 510(k) clearance on 2023-06-30, under approval number K230991.

What company makes PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is manufactured by Given Imaging Ltd. (Medtronic).

What is the FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

The FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is NEZ.

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Related PubMed Literature

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Other Devices by Given Imaging Ltd. (Medtronic)

K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Related Devices (Code: NEZ)

K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. K151635CapsoCam (SV-1)CapsoVision, Inc. K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd. K170839RAPID WebGiven Imaging , Ltd. K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc. K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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