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FDA 510(k)

SP Electrocautery Device (SP20)

K-Number: K260287 · 2026-02-24

ApplicantSingle Pass, Inc.
Decision Date2026-02-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SP Electrocautery Device (SP20) 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 2026-02-24 under 510(k) number K260287. 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 SP Electrocautery Device (SP20)?

SP Electrocautery Device (SP20) is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Single Pass, Inc.. The 510(k) number is K260287.

When did SP Electrocautery Device (SP20) receive FDA 510(k) clearance?

SP Electrocautery Device (SP20) received FDA 510(k) clearance on 2026-02-24, under 510(k) number K260287.

Who is the listed applicant for SP Electrocautery Device (SP20)?

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 SP Electrocautery Device (SP20)?

The FDA product code for SP Electrocautery Device (SP20) 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.

K232805Kronos Electrocautery Device

Related Devices (Code: GEI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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