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FDA 510(k)

UROLOGICAL STONE BASKET

K-Number: K891254 · 1989-03-22

ApplicantNorthgate Research, Inc.
Decision Date1989-03-22
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLOGICAL STONE BASKET is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Research, Inc.. It received FDA 510(k) clearance on 1989-03-22 under 510(k) number K891254. 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 UROLOGICAL STONE BASKET?

UROLOGICAL STONE BASKET is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Northgate Research, Inc.. The 510(k) number is K891254.

When did UROLOGICAL STONE BASKET receive FDA 510(k) clearance?

UROLOGICAL STONE BASKET received FDA 510(k) clearance on 1989-03-22, under 510(k) number K891254.

Who is the listed applicant for UROLOGICAL STONE BASKET?

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

What is the FDA product code for UROLOGICAL STONE BASKET?

The FDA product code for UROLOGICAL STONE BASKET 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.

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Other records listing Northgate Research, 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.

K9033371.9 FRENCH LITHOTRIPTER ELECTRODEK8947042.5 FRENCH LITHOTRIPTOR ELECTRODEK891253UROLOGICAL GRASPING FORCEPSK891252UROLOGICAL LOOP RETRIEVERSK8649043F ELECTRODEK8528745F ELECTRODE(LITHOTRIPTOR)

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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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