FDA 510(k)

POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS

K-Number: K052415 · 2005-09-29

ApplicantPower Medical Interventions, Inc.

Decision Date2005-09-29

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS 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 2005-09-29 under 510(k) number K052415. 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 LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS?

POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS is a medical device that received FDA 510(k) clearance on 2005-09-29. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K052415.

When did POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS receive FDA 510(k) clearance?

POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS received FDA 510(k) clearance on 2005-09-29, under 510(k) number K052415.

Who is the listed applicant for POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS 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 POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS?

The FDA product code for POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS is GDW.

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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

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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.