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FDA 510(k)

TRO-GARD

K-Number: K910678 · 1991-05-08

ApplicantConmedcorp
Decision Date1991-05-08
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRO-GARD is the device name listed in this FDA 510(k) record. The listed applicant is Conmedcorp. It received FDA 510(k) clearance on 1991-05-08 under 510(k) number K910678. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRO-GARD?

TRO-GARD is a medical device that received FDA 510(k) clearance on 1991-05-08. The listed applicant is Conmedcorp. The 510(k) number is K910678.

When did TRO-GARD receive FDA 510(k) clearance?

TRO-GARD received FDA 510(k) clearance on 1991-05-08, under 510(k) number K910678.

Who is the listed applicant for TRO-GARD?

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

What is the FDA product code for TRO-GARD?

The FDA product code for TRO-GARD is KGX.

Other records listing Conmedcorp as applicant

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Related Devices (Code: KGX)

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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