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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 a medical device manufactured by Single Pass, Inc.. It received FDA 510(k) clearance on 2026-02-24 under approval 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. It is manufactured by Single Pass, Inc.. The 510(k) number is K260287.

When was SP Electrocautery Device (SP20) approved by the FDA?

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

What company makes SP Electrocautery Device (SP20)?

SP Electrocautery Device (SP20) is manufactured by Single Pass, Inc..

What is the FDA product code for SP Electrocautery Device (SP20)?

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

Other Devices by Single Pass, Inc.

K232805Kronos Electrocautery Device

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Official Source

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