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FDA 510(k)

SURGISCAN SCANNER

K-Number: K952299 · 1995-07-17

ApplicantNorcross Scientific
Decision Date1995-07-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISCAN SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Norcross Scientific. It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K952299. 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 SURGISCAN SCANNER?

SURGISCAN SCANNER is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Norcross Scientific. The 510(k) number is K952299.

When did SURGISCAN SCANNER receive FDA 510(k) clearance?

SURGISCAN SCANNER received FDA 510(k) clearance on 1995-07-17, under 510(k) number K952299.

Who is the listed applicant for SURGISCAN SCANNER?

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

What is the FDA product code for SURGISCAN SCANNER?

The FDA product code for SURGISCAN SCANNER 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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