FDA 510(k)

SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45

K-Number: K012809 · 2001-10-26

ApplicantPower Medical Interventions, Inc.

Decision Date2001-10-26

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 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 2001-10-26 under 510(k) number K012809. 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 DLU - 45MM, MODEL RALC45?

SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K012809.

When did SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 receive FDA 510(k) clearance?

SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 received FDA 510(k) clearance on 2001-10-26, under 510(k) number K012809.

Who is the listed applicant for SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45?

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 DLU - 45MM, MODEL RALC45?

The FDA product code for SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 is GDW.

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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.