FDA 510(k)

PHACO FRAGMENTOR GT-1

K-Number: K834453 · 1984-03-16

Decision Date1984-03-16

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PHACO FRAGMENTOR GT-1 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 1984-03-16 under 510(k) number K834453. 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 PHACO FRAGMENTOR GT-1?

PHACO FRAGMENTOR GT-1 is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Fibra Sonics, Inc.. The 510(k) number is K834453.

When did PHACO FRAGMENTOR GT-1 receive FDA 510(k) clearance?

PHACO FRAGMENTOR GT-1 received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834453.

Who is the listed applicant for PHACO FRAGMENTOR GT-1?

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 PHACO FRAGMENTOR GT-1?

The FDA product code for PHACO FRAGMENTOR GT-1 is HQC.

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Other records listing Fibra Sonics, Inc. as applicant

K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 K984199EXONIX K984143FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM K983199FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL K980930FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA K842024ULTRASONIC LITHOTRIPTOR 300A

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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.