FDA 510(k)

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER

K-Number: K980617 · 1998-04-09

Decision Date1998-04-09

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Urohealth Systems, Inc.. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K980617. 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 MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER?

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is Urohealth Systems, Inc.. The 510(k) number is K980617.

When did MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER receive FDA 510(k) clearance?

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER received FDA 510(k) clearance on 1998-04-09, under 510(k) number K980617.

Who is the listed applicant for MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER?

The FDA 510(k) record lists Urohealth Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER?

The FDA product code for MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER is GDW.

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Official Source

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