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FDA 510(k)

02-10,001

K-Number: K910062 · 1991-08-16

ApplicantLaser Engineering, Inc.
Decision Date1991-08-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

02-10,001 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Engineering, Inc.. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K910062. 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 02-10,001?

02-10,001 is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Laser Engineering, Inc.. The 510(k) number is K910062.

When did 02-10,001 receive FDA 510(k) clearance?

02-10,001 received FDA 510(k) clearance on 1991-08-16, under 510(k) number K910062.

Who is the listed applicant for 02-10,001?

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

What is the FDA product code for 02-10,001?

The FDA product code for 02-10,001 is GEX. This falls under the Gastroenterology category.

Other records listing Laser Engineering, 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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