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FDA 510(k)

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

K-Number: K191933 · 2019-08-16

ApplicantJohnson & Johnson Surgical Vision, Inc.
Decision Date2019-08-16
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal 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 2019-08-16 under 510(k) number K191933. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal?

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K191933.

When did COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal receive FDA 510(k) clearance?

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191933.

Who is the listed applicant for COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal?

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 COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal?

The FDA product code for COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal is HQC.

Related Clinical Trials

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

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.

PMA P810031AID, SURGICAL, VISCOELASTICPMA P980040intraocular lensPMA P990080intraocular lensPMA P080010Lens, multifocal intraocularPMA P110007AID, SURGICAL, VISCOELASTICPMA P880081Unknown Device

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Related Devices (Code: HQC)

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.

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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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