FDA 510(k)

POWER EXTENDERS MODEL# PEC200, PES200,PES200S

K-Number: K063746 · 2007-01-12

ApplicantPower Medical Interventions, Inc.

Decision Date2007-01-12

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

POWER EXTENDERS MODEL# PEC200, PES200,PES200S 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 2007-01-12 under 510(k) number K063746. 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 POWER EXTENDERS MODEL# PEC200, PES200,PES200S?

POWER EXTENDERS MODEL# PEC200, PES200,PES200S is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K063746.

When did POWER EXTENDERS MODEL# PEC200, PES200,PES200S receive FDA 510(k) clearance?

POWER EXTENDERS MODEL# PEC200, PES200,PES200S received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063746.

Who is the listed applicant for POWER EXTENDERS MODEL# PEC200, PES200,PES200S?

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 POWER EXTENDERS MODEL# PEC200, PES200,PES200S?

The FDA product code for POWER EXTENDERS MODEL# PEC200, PES200,PES200S is GDW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Power Medical Interventions, Inc. as applicant

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 K071708I45, I45S, I60, AND I60S

View all 22 devices →

Related Devices (Code: GDW)

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.