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FDA 510(k)

STONE BASKET

K-Number: K914505 · 1991-12-09

ApplicantSurgitek Medical Engineering Corp.
Decision Date1991-12-09
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STONE BASKET is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek Medical Engineering Corp.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K914505. 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 STONE BASKET?

STONE BASKET is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Surgitek Medical Engineering Corp.. The 510(k) number is K914505.

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

STONE BASKET received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914505.

Who is the listed applicant for STONE BASKET?

The FDA 510(k) record lists Surgitek Medical Engineering Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STONE BASKET?

The FDA product code for 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 Surgitek Medical Engineering Corp. 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.

K914504CYTOLOGY BRUSHK914495E.R.C.P. CATHETERK914497BIOPSY FORCEPSK914496SCLEROTHERAPY NEEDLEK914503GRASPING FORCEPSK913928SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT

View all 11 devices →

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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