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 the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) 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. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K191949.

When did UNFOLDER Vitan Inserter receive FDA 510(k) clearance?

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

Who is the listed applicant for UNFOLDER Vitan Inserter?

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

What is the FDA product code for UNFOLDER Vitan Inserter?

The FDA product code for UNFOLDER Vitan Inserter is MSS.

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Other records listing Johnson & Johnson Surgical Vision, Inc. as applicant

PMA P810031AID, SURGICAL, VISCOELASTIC PMA P980040intraocular lens PMA P990080intraocular lens PMA P080010Lens, multifocal intraocular PMA P110007AID, SURGICAL, VISCOELASTIC PMA P880081Unknown Device

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Related Devices (Code: MSS)

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated K231106Accuject Refra Injector AR2900Medicel AG K231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight 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.