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)

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING

K-Number: K895885 · 1990-02-09

ApplicantNational-Standard Co.
Decision Date1990-02-09
Product CodeFCI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING is the device name listed in this FDA 510(k) record. The listed applicant is National-Standard Co.. It received FDA 510(k) clearance on 1990-02-09 under 510(k) number K895885. The device is classified under product code FCI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING?

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING is a medical device that received FDA 510(k) clearance on 1990-02-09. The listed applicant is National-Standard Co.. The 510(k) number is K895885.

When did AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING receive FDA 510(k) clearance?

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING received FDA 510(k) clearance on 1990-02-09, under 510(k) number K895885.

Who is the listed applicant for AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING?

The FDA 510(k) record lists National-Standard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING?

The FDA product code for AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING is FCI.

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

Related Devices (Code: FCI)

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.

K894627BT-338N ELECTRONIC CLINICAL THERMOMETERIntegrated Display Technology, Ltd.K875119BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBEAdvanced Diagnostic Medical Systems, Inc.K853104DISPOSABLE, STERILE BIOPSY PUNCHAugust C. Stiefel Research Institute, Inc.K831317BIOPSY ATTACHMENTDiasonics, Inc.

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.

↑