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FDA 510(k)

INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT

K-Number: K091215 · 2009-05-18

ApplicantPower Medical Interventions, Inc.
Decision Date2009-05-18
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Power Medical Interventions, Inc.. It received FDA 510(k) clearance on 2009-05-18 under 510(k) number K091215. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT?

INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 2009-05-18. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K091215.

When did INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT receive FDA 510(k) clearance?

INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT received FDA 510(k) clearance on 2009-05-18, under 510(k) number K091215.

Who is the listed applicant for INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT?

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

What is the FDA product code for INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT?

The FDA product code for INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT is GDW.

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Official Source

View on FDA Database →

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

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