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FDA 510(k)

COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015

K-Number: K082803 · 2008-11-13

ApplicantPercutaneous Systems, Inc.
Decision Date2008-11-13
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 is the device name listed in this FDA 510(k) record. The listed applicant is Percutaneous Systems, Inc.. It received FDA 510(k) clearance on 2008-11-13 under 510(k) number K082803. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015?

COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 is a medical device that received FDA 510(k) clearance on 2008-11-13. The listed applicant is Percutaneous Systems, Inc.. The 510(k) number is K082803.

When did COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 receive FDA 510(k) clearance?

COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 received FDA 510(k) clearance on 2008-11-13, under 510(k) number K082803.

Who is the listed applicant for COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015?

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

What is the FDA product code for COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015?

The FDA product code for COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 is FFL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Percutaneous Systems, Inc. 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.

K102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510K052134CYSTOGLIDE DILATING INTRODUCER SHEATHK042877MICROVERTER URETERAL ACCESS SHEATHK040519SLIP UROLOGY CATHETERK040520SLIP UROLOGY INTRODUCER SHEATH

Related Devices (Code: FFL)

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.

K190492Peralta Stone Removal CatheterCalcula Technologies, Inc.K172299Accordion Piccolo Stone Management DeviceThs International, Inc. D/B/A Accordion MedicalK102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510Percutaneous Systems, Inc.K052048ACCORDIONPercutaneous Systems, IncorporatedK012581REPROCESSED STONE RETRIEVAL BASKETSSterilmed, Inc.K972091AMS FOREIGN BODY EXTRATORAmerican Medical Systems, Inc.

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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