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FDA 510(k)

Electro-Spec Steri-Caps

K-Number: K231905 · 2023-08-14

ApplicantElectro-Spec, Inc.
Decision Date2023-08-14
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Electro-Spec Steri-Caps is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Spec, Inc.. It received FDA 510(k) clearance on 2023-08-14 under 510(k) number K231905. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electro-Spec Steri-Caps?

Electro-Spec Steri-Caps is a medical device that received FDA 510(k) clearance on 2023-08-14. The listed applicant is Electro-Spec, Inc.. The 510(k) number is K231905.

When did Electro-Spec Steri-Caps receive FDA 510(k) clearance?

Electro-Spec Steri-Caps received FDA 510(k) clearance on 2023-08-14, under 510(k) number K231905.

Who is the listed applicant for Electro-Spec Steri-Caps?

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

What is the FDA product code for Electro-Spec Steri-Caps?

The FDA product code for Electro-Spec Steri-Caps is HTY.

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Official Source

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