Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BAUER FLEXI-TEMNO BIOPSY NEEDLE

K-Number: K902320 · 1990-10-01

ApplicantProact, Ltd.
Decision Date1990-10-01
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAUER FLEXI-TEMNO BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Proact, Ltd.. It received FDA 510(k) clearance on 1990-10-01 under 510(k) number K902320. 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 BAUER FLEXI-TEMNO BIOPSY NEEDLE?

BAUER FLEXI-TEMNO BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1990-10-01. The listed applicant is Proact, Ltd.. The 510(k) number is K902320.

When did BAUER FLEXI-TEMNO BIOPSY NEEDLE receive FDA 510(k) clearance?

BAUER FLEXI-TEMNO BIOPSY NEEDLE received FDA 510(k) clearance on 1990-10-01, under 510(k) number K902320.

Who is the listed applicant for BAUER FLEXI-TEMNO BIOPSY NEEDLE?

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

What is the FDA product code for BAUER FLEXI-TEMNO BIOPSY NEEDLE?

The FDA product code for BAUER FLEXI-TEMNO BIOPSY NEEDLE is FCG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Proact, Ltd. 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.

K941256QUICK CORE IIK926559PROACT BIOPSY NEEDLE ENCHANCEMENTSK913306BONE-TEMNO/STERNUM-TEMNOK902319BAUER TEMNO BIOPSY NEEDLE

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.

↑