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FDA 510(k)

ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM

K-Number: K913566 · 1993-04-20

ApplicantAlfred O. Bonati, M.D.
Decision Date1993-04-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM is the device name listed in this FDA 510(k) record. The listed applicant is Alfred O. Bonati, M.D.. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K913566. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM?

ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Alfred O. Bonati, M.D.. The 510(k) number is K913566.

When did ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM receive FDA 510(k) clearance?

ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM received FDA 510(k) clearance on 1993-04-20, under 510(k) number K913566.

Who is the listed applicant for ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM?

The FDA 510(k) record lists Alfred O. Bonati, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM?

The FDA product code for ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM is GEX. This falls under the Gastroenterology category.

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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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