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FDA 510(k)

SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40

K-Number: K921146 · 1992-06-08

ApplicantSharplan Lasers, Inc.
Decision Date1992-06-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 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 1992-06-08 under 510(k) number K921146. 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 CO2 SURG. LASER, MO. 1039 SURGICENTER 40?

SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 is a medical device that received FDA 510(k) clearance on 1992-06-08. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K921146.

When did SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 receive FDA 510(k) clearance?

SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 received FDA 510(k) clearance on 1992-06-08, under 510(k) number K921146.

Who is the listed applicant for SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40?

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 CO2 SURG. LASER, MO. 1039 SURGICENTER 40?

The FDA product code for SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 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)

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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