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FDA 510(k)

SUN MEDICAL SMOKE EVACUATOR SYSTEM

K-Number: K874948 · 1988-02-18

ApplicantSun Medical, Inc.
Decision Date1988-02-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUN MEDICAL SMOKE EVACUATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sun Medical, Inc.. It received FDA 510(k) clearance on 1988-02-18 under 510(k) number K874948. 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 SUN MEDICAL SMOKE EVACUATOR SYSTEM?

SUN MEDICAL SMOKE EVACUATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is Sun Medical, Inc.. The 510(k) number is K874948.

When did SUN MEDICAL SMOKE EVACUATOR SYSTEM receive FDA 510(k) clearance?

SUN MEDICAL SMOKE EVACUATOR SYSTEM received FDA 510(k) clearance on 1988-02-18, under 510(k) number K874948.

Who is the listed applicant for SUN MEDICAL SMOKE EVACUATOR SYSTEM?

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

What is the FDA product code for SUN MEDICAL SMOKE EVACUATOR SYSTEM?

The FDA product code for SUN MEDICAL SMOKE EVACUATOR SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Sun Medical, 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.

K921963DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900K911154SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200K845006SUN MEDICAL LAMINARIA CERVICAL DILATOR

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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