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FDA 510(k)

DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT

K-Number: K950662 · 1995-03-10

ApplicantLaserscope
Decision Date1995-03-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K950662. 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 DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT?

DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Laserscope. The 510(k) number is K950662.

When did DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT receive FDA 510(k) clearance?

DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT received FDA 510(k) clearance on 1995-03-10, under 510(k) number K950662.

Who is the listed applicant for DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT?

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

What is the FDA product code for DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT?

The FDA product code for DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT is GEX. This falls under the Gastroenterology category.

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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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