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FDA 510(k)

MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE

K-Number: K891088 · 1989-03-17

ApplicantSharplan Lasers, Inc.
Decision Date1989-03-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE 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 1989-03-17 under 510(k) number K891088. 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 MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE?

MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K891088.

When did MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE receive FDA 510(k) clearance?

MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE received FDA 510(k) clearance on 1989-03-17, under 510(k) number K891088.

Who is the listed applicant for MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE?

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 MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE?

The FDA product code for MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE 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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