FDA 510(k)

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

Numéro K : K233229 · 2024-01-05

Date de décision2024-01-05

Code produitNEZ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corporation. It received FDA 510(k) clearance on 2024-01-05 under 510(k) number K233229. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is a medical device that received FDA 510(k) clearance on 2024-01-05. The listed applicant is Anx Robotica Corporation. The 510(k) number is K233229.

When did NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether receive FDA 510(k) clearance?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether received FDA 510(k) clearance on 2024-01-05, under 510(k) number K233229.

Who is the listed applicant for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

The FDA 510(k) record lists Anx Robotica Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

The FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is NEZ.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Anx Robotica Corporation en tant que demandeur

K250493MotiliCap GI Monitoring System K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether

Dispositifs connexes (Code : NEZ)

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.

Source officielle

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