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FDA 510(k)

PKS BILL

K-Number: K122605 · 2012-12-05

ApplicantGyrus Acmi, Inc.
Decision Date2012-12-05
Product CodeHIN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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 2012-12-05 under 510(k) number K122605. 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 PKS BILL?

PKS BILL is a medical device that received FDA 510(k) clearance on 2012-12-05. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K122605.

When did PKS BILL receive FDA 510(k) clearance?

PKS BILL received FDA 510(k) clearance on 2012-12-05, under 510(k) number K122605.

Who is the listed applicant for 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 PKS BILL?

The FDA product code for PKS BILL is HIN.

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Related Devices (Code: HIN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130305LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZELina Medical ApsK122983KSEA BIPOLAR ELECTRODEKARL STORZ Endoscopy-America, Inc.K113080TUBALGATORMectra Labs, Inc.K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSETHICON, Inc.K111059GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)Gyrus Acmi, Inc.K990147BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771Richard Wolf Medical Instruments Corp.

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.

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