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FDA 510(k)

RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE

K-Number: K040763 · 2004-04-08

ApplicantResect Medical, Inc.
Decision Date2004-04-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Resect Medical, Inc.. It received FDA 510(k) clearance on 2004-04-08 under 510(k) number K040763. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE?

RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE is a medical device that received FDA 510(k) clearance on 2004-04-08. The listed applicant is Resect Medical, Inc.. The 510(k) number is K040763.

When did RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE receive FDA 510(k) clearance?

RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE received FDA 510(k) clearance on 2004-04-08, under 510(k) number K040763.

Who is the listed applicant for RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE?

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

What is the FDA product code for RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE?

The FDA product code for RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE is GEI.

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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.

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