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FDA 510(k)

PARASCAN SCANNING DEVICE

K-Number: K964520 · 1997-02-10

ApplicantLaserscope
Decision Date1997-02-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARASCAN SCANNING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K964520. 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 PARASCAN SCANNING DEVICE?

PARASCAN SCANNING DEVICE is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Laserscope. The 510(k) number is K964520.

When did PARASCAN SCANNING DEVICE receive FDA 510(k) clearance?

PARASCAN SCANNING DEVICE received FDA 510(k) clearance on 1997-02-10, under 510(k) number K964520.

Who is the listed applicant for PARASCAN SCANNING DEVICE?

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 PARASCAN SCANNING DEVICE?

The FDA product code for PARASCAN SCANNING DEVICE is GEX. This falls under the Gastroenterology category.

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Other records listing Laserscope as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

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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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