PillCam Genius

FDA UDI

Class II (US FDA UDI)

by Given Imaging , Ltd.

Identity

Trade Name: PillCam Genius FDA UDI
Generic Name: Video capsule endoscopy system capsule FDA UDI
Device Name: SB Capsule Endoscopy Kit FDA UDI
Model / Reference: FGS-0689 FDA UDI
Description: SB Capsule Endoscopy Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521845848 FDA UDI
510(k) Number: K240276 FDA UDI
FDA Product Code: NEZ FDA UDI
GMDN Term: Video capsule endoscopy system capsule FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Video capsule endoscopy system capsule

PillCam Genius by Given Imaging , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy system capsule.

MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET — Olympus Medical Systems Corporation · Class II
NaviCam Small Bowel Capsule Endoscopy System — ANKON Technologies Co., Ltd. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
NaviCam Capsule Endoscope System — ANX ROBOTICA CORP. · Class II
NaviCam Tether — ANX ROBOTICA CORP. · Class II

Cleared under the same submission

K240276 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Given Imaging , Ltd.

Sources (1)

FDA UDI 67eab3de-92df-41e9-adbf-c1160375f42b 36 fields · synced May 30, 2026