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FDA 510(k)

Scope ProTech

K-Number: K191011 · 2019-05-07

ApplicantMeditech Endoscopy, Ltd.
Decision Date2019-05-07
Product CodeOCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Scope ProTech is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Endoscopy, Ltd.. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K191011. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scope ProTech?

Scope ProTech is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Meditech Endoscopy, Ltd.. The 510(k) number is K191011.

When did Scope ProTech receive FDA 510(k) clearance?

Scope ProTech received FDA 510(k) clearance on 2019-05-07, under 510(k) number K191011.

Who is the listed applicant for Scope ProTech?

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

What is the FDA product code for Scope ProTech?

The FDA product code for Scope ProTech is OCU.

Related Devices (Code: OCU)

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.

K202838Andorate Universal Endoscope Tip GuardGa Health Company LimitedK191715Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileSTERIS Corporation

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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