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FDA 510(k)

PVL-4.8-200 BALLOON STONE EXTRACTOR

K-Number: K851954 · 1985-12-17

Decision Date1985-12-17
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PVL-4.8-200 BALLOON STONE EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 1985-12-17 under 510(k) number K851954. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVL-4.8-200 BALLOON STONE EXTRACTOR?

PVL-4.8-200 BALLOON STONE EXTRACTOR is a medical device that received FDA 510(k) clearance on 1985-12-17. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K851954.

When did PVL-4.8-200 BALLOON STONE EXTRACTOR receive FDA 510(k) clearance?

PVL-4.8-200 BALLOON STONE EXTRACTOR received FDA 510(k) clearance on 1985-12-17, under 510(k) number K851954.

Who is the listed applicant for PVL-4.8-200 BALLOON STONE EXTRACTOR?

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

What is the FDA product code for PVL-4.8-200 BALLOON STONE EXTRACTOR?

The FDA product code for PVL-4.8-200 BALLOON STONE EXTRACTOR is FGE.

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.

Other records listing Wilson-Cook Medical, 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.

View all 122 devices →

Related Devices (Code: FGE)

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.

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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