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FDA 510(k)

COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003

K-Number: K090485 · 2009-07-22

ApplicantPercutaneous Systems, Incorporated
Decision Date2009-07-22
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 is the device name listed in this FDA 510(k) record. The listed applicant is Percutaneous Systems, Incorporated. It received FDA 510(k) clearance on 2009-07-22 under 510(k) number K090485. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003?

COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 is a medical device that received FDA 510(k) clearance on 2009-07-22. The listed applicant is Percutaneous Systems, Incorporated. The 510(k) number is K090485.

When did COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 receive FDA 510(k) clearance?

COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 received FDA 510(k) clearance on 2009-07-22, under 510(k) number K090485.

Who is the listed applicant for COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003?

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

What is the FDA product code for COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003?

The FDA product code for COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 is LQR.

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Other records listing Percutaneous Systems, Incorporated as applicant

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.

K061766EXPRESSWAY INTERMITTENT CATHETERK052298CYSTOGLIDE INTRODUCER SHEATHK052048ACCORDIONK042531UPDATED SLIP UROLOGY INTRODUCER SHEATH

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Official Source

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