FDA 510(k)

I45, I45S, I60, AND I60S

K-Number: K071708 · 2007-09-27

ApplicantPower Medical Interventions, Inc.

Decision Date2007-09-27

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

I45, I45S, I60, AND I60S 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 2007-09-27 under 510(k) number K071708. 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 I45, I45S, I60, AND I60S?

I45, I45S, I60, AND I60S is a medical device that received FDA 510(k) clearance on 2007-09-27. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K071708.

When did I45, I45S, I60, AND I60S receive FDA 510(k) clearance?

I45, I45S, I60, AND I60S received FDA 510(k) clearance on 2007-09-27, under 510(k) number K071708.

Who is the listed applicant for I45, I45S, I60, AND I60S?

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 I45, I45S, I60, AND I60S?

The FDA product code for I45, I45S, I60, AND I60S is GDW.

Other records listing Power Medical Interventions, 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.

K091215INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT K083527INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS K081826INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V K073001IDRIVES, IDRIVEC, IDRIVEF K073148IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS K063746POWER EXTENDERS MODEL# PEC200, PES200,PES200S

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Related Devices (Code: GDW)

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.