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FDA 510(k)

CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS

K-Number: K932272 · 1993-10-12

ApplicantLc Ent.
Decision Date1993-10-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS is the device name listed in this FDA 510(k) record. The listed applicant is Lc Ent.. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K932272. 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 CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS?

CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Lc Ent.. The 510(k) number is K932272.

When did CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS receive FDA 510(k) clearance?

CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS received FDA 510(k) clearance on 1993-10-12, under 510(k) number K932272.

Who is the listed applicant for CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS?

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

What is the FDA product code for CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS?

The FDA product code for CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS 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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