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FDA 510(k)

SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040

K-Number: K001263 · 2000-05-05

ApplicantE S C Sharplan
Decision Date2000-05-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 is the device name listed in this FDA 510(k) record. The listed applicant is E S C Sharplan. It received FDA 510(k) clearance on 2000-05-05 under 510(k) number K001263. 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 SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040?

SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 is a medical device that received FDA 510(k) clearance on 2000-05-05. The listed applicant is E S C Sharplan. The 510(k) number is K001263.

When did SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 receive FDA 510(k) clearance?

SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 received FDA 510(k) clearance on 2000-05-05, under 510(k) number K001263.

Who is the listed applicant for SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040?

The FDA 510(k) record lists E S C Sharplan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040?

The FDA product code for SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 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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