FDA 510(k)

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)

K-Number: K111059 · 2011-09-01

Decision Date2011-09-01

Product CodeHIN

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2011-09-01 under 510(k) number K111059. The device is classified under product code HIN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)?

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) is a medical device that received FDA 510(k) clearance on 2011-09-01. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K111059.

When did GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) receive FDA 510(k) clearance?

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) received FDA 510(k) clearance on 2011-09-01, under 510(k) number K111059.

Who is the listed applicant for GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)?

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

What is the FDA product code for GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)?

The FDA product code for GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) is HIN.

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Related Devices (Code: HIN)

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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.