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FDA 510(k)

4-WIRE (CARSON) STONE EXTRACTOR

K-Number: K863081 · 1986-10-24

ApplicantCook Urological, Inc.
Decision Date1986-10-24
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4-WIRE (CARSON) STONE EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863081. 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 4-WIRE (CARSON) STONE EXTRACTOR?

4-WIRE (CARSON) STONE EXTRACTOR is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Cook Urological, Inc.. The 510(k) number is K863081.

When did 4-WIRE (CARSON) STONE EXTRACTOR receive FDA 510(k) clearance?

4-WIRE (CARSON) STONE EXTRACTOR received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863081.

Who is the listed applicant for 4-WIRE (CARSON) STONE EXTRACTOR?

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

What is the FDA product code for 4-WIRE (CARSON) STONE EXTRACTOR?

The FDA product code for 4-WIRE (CARSON) STONE EXTRACTOR is FFL.

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Other records listing Cook Urological, 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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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.K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015Percutaneous Systems, Inc.K052048ACCORDIONPercutaneous Systems, IncorporatedK012581REPROCESSED STONE RETRIEVAL BASKETSSterilmed, Inc.

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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