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FDA 510(k)

HELICAL STONE/FLATWIRE STONE BASKETS

K-Number: K933260 · 1994-01-11

ApplicantSurgitek
Decision Date1994-01-11
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HELICAL STONE/FLATWIRE STONE BASKETS is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1994-01-11 under 510(k) number K933260. 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 HELICAL STONE/FLATWIRE STONE BASKETS?

HELICAL STONE/FLATWIRE STONE BASKETS is a medical device that received FDA 510(k) clearance on 1994-01-11. The listed applicant is Surgitek. The 510(k) number is K933260.

When did HELICAL STONE/FLATWIRE STONE BASKETS receive FDA 510(k) clearance?

HELICAL STONE/FLATWIRE STONE BASKETS received FDA 510(k) clearance on 1994-01-11, under 510(k) number K933260.

Who is the listed applicant for HELICAL STONE/FLATWIRE STONE BASKETS?

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

What is the FDA product code for HELICAL STONE/FLATWIRE STONE BASKETS?

The FDA product code for HELICAL STONE/FLATWIRE STONE BASKETS is FFL.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933261GRASPING FORCEPSK930733URETERAL STENT

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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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