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FDA 510(k)

ALLOY SCALPEL HANDPIECES, MODIFICATION

K-Number: K925726 · 1993-11-22

ApplicantLca, Inc.
Decision Date1993-11-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALLOY SCALPEL HANDPIECES, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Lca, Inc.. It received FDA 510(k) clearance on 1993-11-22 under 510(k) number K925726. 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 ALLOY SCALPEL HANDPIECES, MODIFICATION?

ALLOY SCALPEL HANDPIECES, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-11-22. The listed applicant is Lca, Inc.. The 510(k) number is K925726.

When did ALLOY SCALPEL HANDPIECES, MODIFICATION receive FDA 510(k) clearance?

ALLOY SCALPEL HANDPIECES, MODIFICATION received FDA 510(k) clearance on 1993-11-22, under 510(k) number K925726.

Who is the listed applicant for ALLOY SCALPEL HANDPIECES, MODIFICATION?

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

What is the FDA product code for ALLOY SCALPEL HANDPIECES, MODIFICATION?

The FDA product code for ALLOY SCALPEL HANDPIECES, MODIFICATION 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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