FDA 510(k)

SURGASSIST FLEXSHAFT 2, MODEL FS2 14

K-Number: K021249 · 2002-05-15

ApplicantPower Medical Interventions, Inc.

Decision Date2002-05-15

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGASSIST FLEXSHAFT 2, MODEL FS2 14 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 2002-05-15 under 510(k) number K021249. 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 FLEXSHAFT 2, MODEL FS2 14?

SURGASSIST FLEXSHAFT 2, MODEL FS2 14 is a medical device that received FDA 510(k) clearance on 2002-05-15. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K021249.

When did SURGASSIST FLEXSHAFT 2, MODEL FS2 14 receive FDA 510(k) clearance?

SURGASSIST FLEXSHAFT 2, MODEL FS2 14 received FDA 510(k) clearance on 2002-05-15, under 510(k) number K021249.

Who is the listed applicant for SURGASSIST FLEXSHAFT 2, MODEL FS2 14?

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 FLEXSHAFT 2, MODEL FS2 14?

The FDA product code for SURGASSIST FLEXSHAFT 2, MODEL FS2 14 is GDW.

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Other records listing Power Medical Interventions, Inc. as applicant

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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.