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FDA 510(k)

VENISECT LASER LANCET

K-Number: K955653 · 1997-04-11

ApplicantVenisect, Inc.
Decision Date1997-04-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VENISECT LASER LANCET is the device name listed in this FDA 510(k) record. The listed applicant is Venisect, Inc.. It received FDA 510(k) clearance on 1997-04-11 under 510(k) number K955653. 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 VENISECT LASER LANCET?

VENISECT LASER LANCET is a medical device that received FDA 510(k) clearance on 1997-04-11. The listed applicant is Venisect, Inc.. The 510(k) number is K955653.

When did VENISECT LASER LANCET receive FDA 510(k) clearance?

VENISECT LASER LANCET received FDA 510(k) clearance on 1997-04-11, under 510(k) number K955653.

Who is the listed applicant for VENISECT LASER LANCET?

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

What is the FDA product code for VENISECT LASER LANCET?

The FDA product code for VENISECT LASER LANCET 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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