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FDA 510(k)

Kronos Electrocautery Device

K-Number: K232805 · 2024-04-25

ApplicantSingle Pass, Inc.
Decision Date2024-04-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kronos Electrocautery Device is the device name listed in this FDA 510(k) record. The listed applicant is Single Pass, Inc.. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K232805. 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 Kronos Electrocautery Device?

Kronos Electrocautery Device is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Single Pass, Inc.. The 510(k) number is K232805.

When did Kronos Electrocautery Device receive FDA 510(k) clearance?

Kronos Electrocautery Device received FDA 510(k) clearance on 2024-04-25, under 510(k) number K232805.

Who is the listed applicant for Kronos Electrocautery Device?

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

What is the FDA product code for Kronos Electrocautery Device?

The FDA product code for Kronos Electrocautery Device is GEI.

Other records listing Single Pass, 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.

K260287SP Electrocautery Device (SP20)

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Official Source

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