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FDA 510(k)

ID-Cap System

K-Number: K183052 · 2019-12-06

ApplicantEtectrx, Inc.
Decision Date2019-12-06
Product CodeOZW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ID-Cap System is the device name listed in this FDA 510(k) record. The listed applicant is Etectrx, Inc.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K183052. The device is classified under product code OZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ID-Cap System?

ID-Cap System is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Etectrx, Inc.. The 510(k) number is K183052.

When did ID-Cap System receive FDA 510(k) clearance?

ID-Cap System received FDA 510(k) clearance on 2019-12-06, under 510(k) number K183052.

Who is the listed applicant for ID-Cap System?

The FDA 510(k) record lists Etectrx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ID-Cap System?

The FDA product code for ID-Cap System is OZW.

Related Devices (Code: OZW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.

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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