FDA 510(k)

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM

K-Number: K984143 · 1999-02-16

Decision Date1999-02-16

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fibra Sonics, Inc.. It received FDA 510(k) clearance on 1999-02-16 under 510(k) number K984143. 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 FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM?

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-16. The listed applicant is Fibra Sonics, Inc.. The 510(k) number is K984143.

When did FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM receive FDA 510(k) clearance?

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM received FDA 510(k) clearance on 1999-02-16, under 510(k) number K984143.

Who is the listed applicant for FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM?

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

What is the FDA product code for FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM?

The FDA product code for FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM is HQC.

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Other records listing Fibra Sonics, Inc. as applicant

K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 K984199EXONIX K983199FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL K980930FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA K842024ULTRASONIC LITHOTRIPTOR 300A K834453PHACO FRAGMENTOR GT-1

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Related Devices (Code: HQC)

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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.