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FDA 510(k)

PHAKOSYSTEMS CT-100 CAUTERY MODULE

K-Number: K860236 · 1986-02-19

ApplicantPhakosystems, Inc.
Decision Date1986-02-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHAKOSYSTEMS CT-100 CAUTERY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Phakosystems, Inc.. It received FDA 510(k) clearance on 1986-02-19 under 510(k) number K860236. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHAKOSYSTEMS CT-100 CAUTERY MODULE?

PHAKOSYSTEMS CT-100 CAUTERY MODULE is a medical device that received FDA 510(k) clearance on 1986-02-19. The listed applicant is Phakosystems, Inc.. The 510(k) number is K860236.

When did PHAKOSYSTEMS CT-100 CAUTERY MODULE receive FDA 510(k) clearance?

PHAKOSYSTEMS CT-100 CAUTERY MODULE received FDA 510(k) clearance on 1986-02-19, under 510(k) number K860236.

Who is the listed applicant for PHAKOSYSTEMS CT-100 CAUTERY MODULE?

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

What is the FDA product code for PHAKOSYSTEMS CT-100 CAUTERY MODULE?

The FDA product code for PHAKOSYSTEMS CT-100 CAUTERY MODULE is GEI.

Related Clinical Trials

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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Other records listing Phakosystems, 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.

K880081VISION CARE/PHAKOSYSTEMS ECHOPACHK871938VISION CARE/PHAKOSYSTEMS ECHORULEK851674PHAKOSYSTEMS MODEL CES 4100K830871PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION

Related Devices (Code: GEI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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