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FDA 510(k)

PRO-CUT BIOPSY NEEDLE

K-Number: K891777 · 1989-05-04

ApplicantTeknar, Inc.
Decision Date1989-05-04
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRO-CUT BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Teknar, Inc.. It received FDA 510(k) clearance on 1989-05-04 under 510(k) number K891777. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-CUT BIOPSY NEEDLE?

PRO-CUT BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1989-05-04. The listed applicant is Teknar, Inc.. The 510(k) number is K891777.

When did PRO-CUT BIOPSY NEEDLE receive FDA 510(k) clearance?

PRO-CUT BIOPSY NEEDLE received FDA 510(k) clearance on 1989-05-04, under 510(k) number K891777.

Who is the listed applicant for PRO-CUT BIOPSY NEEDLE?

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

What is the FDA product code for PRO-CUT BIOPSY NEEDLE?

The FDA product code for PRO-CUT BIOPSY NEEDLE is FCG.

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Other records listing Teknar, 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.

K903666OPHTHASONIC A/P IIIK896038B-SCAN 10 MHZ PROBEK896150IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONICK883965PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTORK881850TEKNAR PERCU-SCANK881605BIOPSY GUIDE

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Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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