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FDA 510(k)

THERMAL OPTION

K-Number: K932790 · 1994-01-28

ApplicantCox Medical Ent., Inc.
Decision Date1994-01-28
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THERMAL OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Cox Medical Ent., Inc.. It received FDA 510(k) clearance on 1994-01-28 under 510(k) number K932790. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAL OPTION?

THERMAL OPTION is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Cox Medical Ent., Inc.. The 510(k) number is K932790.

When did THERMAL OPTION receive FDA 510(k) clearance?

THERMAL OPTION received FDA 510(k) clearance on 1994-01-28, under 510(k) number K932790.

Who is the listed applicant for THERMAL OPTION?

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

What is the FDA product code for THERMAL OPTION?

The FDA product code for THERMAL OPTION is KGE.

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Other records listing Cox Medical Ent., Inc. as applicant

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K950689UCBK946360MODULAR BIOPSY FORCEPK941464BASICS ENDOSCOPY SYSTEMK940911BASICS ENDOSCOPY SYSTEMK935250ACCU-PATHK924655COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)

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Related Devices (Code: KGE)

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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