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FDA 510(k)

BALLOON DILATION HELICAL STONE EXTRACT

K-Number: K831875 · 1983-09-12

ApplicantVpi
Decision Date1983-09-12
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BALLOON DILATION HELICAL STONE EXTRACT is the device name listed in this FDA 510(k) record. The listed applicant is Vpi. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831875. 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 BALLOON DILATION HELICAL STONE EXTRACT?

BALLOON DILATION HELICAL STONE EXTRACT is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Vpi. The 510(k) number is K831875.

When did BALLOON DILATION HELICAL STONE EXTRACT receive FDA 510(k) clearance?

BALLOON DILATION HELICAL STONE EXTRACT received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831875.

Who is the listed applicant for BALLOON DILATION HELICAL STONE EXTRACT?

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

What is the FDA product code for BALLOON DILATION HELICAL STONE EXTRACT?

The FDA product code for BALLOON DILATION HELICAL STONE EXTRACT 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 Vpi 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.

K833762PERCUTANEOUS RETROGRADE NEPHROSTOMY

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

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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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