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FDA 510(k)

STERI-TRACT

K-Number: K811863 · 1981-09-21

ApplicantRogo Ent.
Decision Date1981-09-21
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERI-TRACT is the device name listed in this FDA 510(k) record. The listed applicant is Rogo Ent.. It received FDA 510(k) clearance on 1981-09-21 under 510(k) number K811863. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERI-TRACT?

STERI-TRACT is a medical device that received FDA 510(k) clearance on 1981-09-21. The listed applicant is Rogo Ent.. The 510(k) number is K811863.

When did STERI-TRACT receive FDA 510(k) clearance?

STERI-TRACT received FDA 510(k) clearance on 1981-09-21, under 510(k) number K811863.

Who is the listed applicant for STERI-TRACT?

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

What is the FDA product code for STERI-TRACT?

The FDA product code for STERI-TRACT is KDJ.

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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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Related Devices (Code: KDJ)

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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