FDA 510(k)

LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L

K-Number: K091440 · 2009-10-09

Decision Date2009-10-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K091440. 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 LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L?

LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Bovie Medical. The 510(k) number is K091440.

When did LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L receive FDA 510(k) clearance?

LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L received FDA 510(k) clearance on 2009-10-09, under 510(k) number K091440.

Who is the listed applicant for LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L?

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

What is the FDA product code for LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L?

The FDA product code for LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L 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.