FDA 510(k)

BIPOLAR PENCIL, MODEL 3901-002, 3900-002

K-Number: K010487 · 2001-05-03

Decision Date2001-05-03

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BIPOLAR PENCIL, MODEL 3901-002, 3900-002 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic PS Medical. It received FDA 510(k) clearance on 2001-05-03 under 510(k) number K010487. 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 BIPOLAR PENCIL, MODEL 3901-002, 3900-002?

BIPOLAR PENCIL, MODEL 3901-002, 3900-002 is a medical device that received FDA 510(k) clearance on 2001-05-03. The listed applicant is Medtronic PS Medical. The 510(k) number is K010487.

When did BIPOLAR PENCIL, MODEL 3901-002, 3900-002 receive FDA 510(k) clearance?

BIPOLAR PENCIL, MODEL 3901-002, 3900-002 received FDA 510(k) clearance on 2001-05-03, under 510(k) number K010487.

Who is the listed applicant for BIPOLAR PENCIL, MODEL 3901-002, 3900-002?

The FDA 510(k) record lists Medtronic PS Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIPOLAR PENCIL, MODEL 3901-002, 3900-002?

The FDA product code for BIPOLAR PENCIL, MODEL 3901-002, 3900-002 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.