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FDA 510(k)

SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE

K-Number: K921596 · 1992-05-13

ApplicantSharplan Lasers, Inc.
Decision Date1992-05-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE 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 1992-05-13 under 510(k) number K921596. 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 C02 ULTRASWIFT VAPORIZATION ENDPIECE?

SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE is a medical device that received FDA 510(k) clearance on 1992-05-13. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K921596.

When did SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE receive FDA 510(k) clearance?

SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE received FDA 510(k) clearance on 1992-05-13, under 510(k) number K921596.

Who is the listed applicant for SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE?

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 C02 ULTRASWIFT VAPORIZATION ENDPIECE?

The FDA product code for SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplan Lasers, Inc. as applicant

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Related Devices (Code: GEX)

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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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