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FDA 510(k)

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV

K-Number: K904658 · 1990-11-20

ApplicantLeigh Med Tech, Inc.
Decision Date1990-11-20
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV is the device name listed in this FDA 510(k) record. The listed applicant is Leigh Med Tech, Inc.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K904658. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV?

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Leigh Med Tech, Inc.. The 510(k) number is K904658.

When did AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV receive FDA 510(k) clearance?

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904658.

Who is the listed applicant for AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV?

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

What is the FDA product code for AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV?

The FDA product code for AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV is KNW.

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Other records listing Leigh Med Tech, 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.

K951147LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER

Related Devices (Code: KNW)

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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