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FDA 510(k)

SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU

K-Number: K881953 · 1988-06-03

ApplicantSharplan Lasers, Inc.
Decision Date1988-06-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU 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 1988-06-03 under 510(k) number K881953. 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 MODELS 719/719SR/719SL COLPOSLAD COS SU?

SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU is a medical device that received FDA 510(k) clearance on 1988-06-03. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K881953.

When did SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU receive FDA 510(k) clearance?

SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU received FDA 510(k) clearance on 1988-06-03, under 510(k) number K881953.

Who is the listed applicant for SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU?

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 MODELS 719/719SR/719SL COLPOSLAD COS SU?

The FDA product code for SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU 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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