FDA 510(k)

POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH

K-Number: K061649 · 2006-09-01

ApplicantPower Medical Interventions, Inc.

Decision Date2006-09-01

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH 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 2006-09-01 under 510(k) number K061649. 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 CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH?

POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH is a medical device that received FDA 510(k) clearance on 2006-09-01. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K061649.

When did POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH receive FDA 510(k) clearance?

POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH received FDA 510(k) clearance on 2006-09-01, under 510(k) number K061649.

Who is the listed applicant for POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH?

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 CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH?

The FDA product code for POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH 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.