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FDA 510(k)

WILTEK BALLOON STONE EXTRACTOR

K-Number: K894865 · 1989-12-21

ApplicantWiltek Medical, Inc.
Decision Date1989-12-21
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK BALLOON STONE EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Wiltek Medical, Inc.. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K894865. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILTEK BALLOON STONE EXTRACTOR?

WILTEK BALLOON STONE EXTRACTOR is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K894865.

When did WILTEK BALLOON STONE EXTRACTOR receive FDA 510(k) clearance?

WILTEK BALLOON STONE EXTRACTOR received FDA 510(k) clearance on 1989-12-21, under 510(k) number K894865.

Who is the listed applicant for WILTEK BALLOON STONE EXTRACTOR?

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

What is the FDA product code for WILTEK BALLOON STONE EXTRACTOR?

The FDA product code for WILTEK BALLOON STONE EXTRACTOR is LQR.

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Other records listing Wiltek 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.

K990231WILTEK HOT BIOPSY FORCEPSK922989WILTEK IRRIGAITON/ASPIRATION TUBE SETK930419WILTEK BIOPSY FORCEPSK914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERK914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERK914131WILTEK ELECTROCAUTERY ADAPTOR

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Related Devices (Code: LQR)

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.

K253056Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd.K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd.K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.K203322SpyGlass Discover Retrieval BasketBoston Scientific Corporation

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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