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FDA 510(k)

EMC FLEXIBLE BIOPSY FORCEPS

K-Number: K941816 · 1994-07-13

ApplicantEnterprise Medical Corp.
Decision Date1994-07-13
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMC FLEXIBLE BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Enterprise Medical Corp.. It received FDA 510(k) clearance on 1994-07-13 under 510(k) number K941816. The device is classified under product code FCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMC FLEXIBLE BIOPSY FORCEPS?

EMC FLEXIBLE BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is Enterprise Medical Corp.. The 510(k) number is K941816.

When did EMC FLEXIBLE BIOPSY FORCEPS receive FDA 510(k) clearance?

EMC FLEXIBLE BIOPSY FORCEPS received FDA 510(k) clearance on 1994-07-13, under 510(k) number K941816.

Who is the listed applicant for EMC FLEXIBLE BIOPSY FORCEPS?

The FDA 510(k) record lists Enterprise Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMC FLEXIBLE BIOPSY FORCEPS?

The FDA product code for EMC FLEXIBLE BIOPSY FORCEPS is FCL.

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 Enterprise Medical Corp. 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.

K942431LAPOROSCOPIC SCISSORSK943583KERRISON RONGEURS

Related Devices (Code: FCL)

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.

K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEOlympus Optical Co., Ltd.K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPSSpectrascience, Inc.K971315AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.K964120INJECTO FLUSHRobert J. Jynch, Jr.K963517SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.K955065OLYMPUS FB SERIES BIOPSY FORCEPSOlympus America, 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.

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