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FDA 510(k)

SHARPLAN SHARPLASE LATERAL ND:YAG FIBER

K-Number: K930582 · 1993-11-02

ApplicantSharplan Lasers, Inc.
Decision Date1993-11-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN SHARPLASE LATERAL ND:YAG FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1993-11-02 under 510(k) number K930582. 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 SHARPLASE LATERAL ND:YAG FIBER?

SHARPLAN SHARPLASE LATERAL ND:YAG FIBER is a medical device that received FDA 510(k) clearance on 1993-11-02. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K930582.

When did SHARPLAN SHARPLASE LATERAL ND:YAG FIBER receive FDA 510(k) clearance?

SHARPLAN SHARPLASE LATERAL ND:YAG FIBER received FDA 510(k) clearance on 1993-11-02, under 510(k) number K930582.

Who is the listed applicant for SHARPLAN SHARPLASE LATERAL ND:YAG FIBER?

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

What is the FDA product code for SHARPLAN SHARPLASE LATERAL ND:YAG FIBER?

The FDA product code for SHARPLAN SHARPLASE LATERAL ND:YAG FIBER is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplan Lasers, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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