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FDA 510(k)

SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET

K-Number: K001563 · 2000-11-22

ApplicantScion Cardiovascular, Inc.
Decision Date2000-11-22
Product CodeFGO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET is the device name listed in this FDA 510(k) record. The listed applicant is Scion Cardiovascular, Inc.. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K001563. The device is classified under product code FGO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET?

SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Scion Cardiovascular, Inc.. The 510(k) number is K001563.

When did SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET receive FDA 510(k) clearance?

SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET received FDA 510(k) clearance on 2000-11-22, under 510(k) number K001563.

Who is the listed applicant for SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET?

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

What is the FDA product code for SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET?

The FDA product code for SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET is FGO.

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.

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Related Devices (Code: FGO)

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.

K970121STONE DISLODGER, BASKETBoston Scientific CorpK963750RETRIEVAL SNAREBoston Scientific CorpK962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.K951309STONE DISLODGER, BASKETBoston Scientific CorpK933261GRASPING FORCEPSSurgitekK934598GRASPING FORCEPS OR RETRIEVAL FORCEPSAnnex Medical, 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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