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FDA 510(k)

INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS

K-Number: K083527 · 2008-12-18

ApplicantPower Medical Interventions, Inc.
Decision Date2008-12-18
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS 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 2008-12-18 under 510(k) number K083527. 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 ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS?

INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K083527.

When did INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS receive FDA 510(k) clearance?

INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS received FDA 510(k) clearance on 2008-12-18, under 510(k) number K083527.

Who is the listed applicant for INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS?

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 ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS?

The FDA product code for INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS is GDW.

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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 INSTRUMENTK081826INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30VK073001IDRIVES, IDRIVEC, IDRIVEFK073148IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONSK071708I45, I45S, I60, AND I60SK063746POWER EXTENDERS MODEL# PEC200, PES200,PES200S

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Official Source

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