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FDA 510(k)

TSI WILLEN-REICH NEEDLE

K-Number: K950726 · 1995-04-18

ApplicantTahoe Surgical Instruments P.R., Inc.
Decision Date1995-04-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TSI WILLEN-REICH NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Tahoe Surgical Instruments P.R., Inc.. It received FDA 510(k) clearance on 1995-04-18 under 510(k) number K950726. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSI WILLEN-REICH NEEDLE?

TSI WILLEN-REICH NEEDLE is a medical device that received FDA 510(k) clearance on 1995-04-18. The listed applicant is Tahoe Surgical Instruments P.R., Inc.. The 510(k) number is K950726.

When did TSI WILLEN-REICH NEEDLE receive FDA 510(k) clearance?

TSI WILLEN-REICH NEEDLE received FDA 510(k) clearance on 1995-04-18, under 510(k) number K950726.

Who is the listed applicant for TSI WILLEN-REICH NEEDLE?

The FDA 510(k) record lists Tahoe Surgical Instruments P.R., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSI WILLEN-REICH NEEDLE?

The FDA product code for TSI WILLEN-REICH NEEDLE is GCJ.

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 Tahoe Surgical Instruments P.R., 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.

K941944TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE

Related Devices (Code: GCJ)

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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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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