FDA 510(k)

SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60

K-Number: K021701 · 2002-06-21

ApplicantPower Medical Interventions, Inc.

Decision Date2002-06-21

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 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 2002-06-21 under 510(k) number K021701. 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 SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60?

SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 is a medical device that received FDA 510(k) clearance on 2002-06-21. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K021701.

When did SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 receive FDA 510(k) clearance?

SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 received FDA 510(k) clearance on 2002-06-21, under 510(k) number K021701.

Who is the listed applicant for SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60?

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 SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60?

The FDA product code for SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 is GDW.

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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.