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FDA 510(k)

HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS

K-Number: K910894 · 1991-04-22

ApplicantHeraeus Lasersonics, Inc.
Decision Date1991-04-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Lasersonics, Inc.. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K910894. 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 HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS?

HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K910894.

When did HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS receive FDA 510(k) clearance?

HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS received FDA 510(k) clearance on 1991-04-22, under 510(k) number K910894.

Who is the listed applicant for HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS?

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

What is the FDA product code for HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS?

The FDA product code for HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS is GEX. This falls under the Gastroenterology category.

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Other records listing Heraeus Lasersonics, Inc. as applicant

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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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