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FDA 510(k)

REPLACE-A-TIP HIGH TEMP. CAUTERY

K-Number: K840433 · 1984-04-25

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-04-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPLACE-A-TIP HIGH TEMP. CAUTERY is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840433. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLACE-A-TIP HIGH TEMP. CAUTERY?

REPLACE-A-TIP HIGH TEMP. CAUTERY is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K840433.

When did REPLACE-A-TIP HIGH TEMP. CAUTERY receive FDA 510(k) clearance?

REPLACE-A-TIP HIGH TEMP. CAUTERY received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840433.

Who is the listed applicant for REPLACE-A-TIP HIGH TEMP. CAUTERY?

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

What is the FDA product code for REPLACE-A-TIP HIGH TEMP. CAUTERY?

The FDA product code for REPLACE-A-TIP HIGH TEMP. CAUTERY is GEI.

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Other records listing Suncoast Medical Manufacturers, 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.

K841604ADJUST-A-TEMP HIGH TEMPERATUREK841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841603ADJUST-A-TEMP MICROK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP TIP

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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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