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FDA 510(k)

UNFOLDER Vitan Inserter

K-Number: K191949 · 2019-09-13

ApplicantJohnson & Johnson Surgical Vision, Inc.
Decision Date2019-09-13
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNFOLDER Vitan Inserter is a medical device manufactured by Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K191949. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNFOLDER Vitan Inserter?

UNFOLDER Vitan Inserter is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K191949.

When was UNFOLDER Vitan Inserter approved by the FDA?

UNFOLDER Vitan Inserter received FDA 510(k) clearance on 2019-09-13, under approval number K191949.

What company makes UNFOLDER Vitan Inserter?

UNFOLDER Vitan Inserter is manufactured by Johnson & Johnson Surgical Vision, Inc..

What is the FDA product code for UNFOLDER Vitan Inserter?

The FDA product code for UNFOLDER Vitan Inserter is MSS.

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Related Devices (Code: MSS)

K161776Lenstec LC Injection systemLenstec, Inc. K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc., K172228pioli IOL Delivery SystemAst Products, Inc. K173480Crystalsert Lens Delivery SystemBausch & Lomb, Inc. K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company K181401RxSight Insertion DeviceRxsight, 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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