FDA 510(k)

ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC

K-Number: K061878 · 2006-10-24

Decision Date2006-10-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC is the device name listed in this FDA 510(k) record. The listed applicant is E Surgical, LLC. It received FDA 510(k) clearance on 2006-10-24 under 510(k) number K061878. 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 ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC?

ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC is a medical device that received FDA 510(k) clearance on 2006-10-24. The listed applicant is E Surgical, LLC. The 510(k) number is K061878.

When did ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC receive FDA 510(k) clearance?

ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC received FDA 510(k) clearance on 2006-10-24, under 510(k) number K061878.

Who is the listed applicant for ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC?

The FDA 510(k) record lists E Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC?

The FDA product code for ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC is GEI.

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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.