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)

ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT

K-Number: K844690 · 1985-01-02

ApplicantJayco Pharmaceuticals
Decision Date1985-01-02
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Jayco Pharmaceuticals. It received FDA 510(k) clearance on 1985-01-02 under 510(k) number K844690. 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 ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT?

ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT is a medical device that received FDA 510(k) clearance on 1985-01-02. The listed applicant is Jayco Pharmaceuticals. The 510(k) number is K844690.

When did ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT receive FDA 510(k) clearance?

ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT received FDA 510(k) clearance on 1985-01-02, under 510(k) number K844690.

Who is the listed applicant for ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT?

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

What is the FDA product code for ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT?

The FDA product code for ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT 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 Jayco Pharmaceuticals 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.

K844689ENDOSCOPIC MANUAL AIR INSUFFLATORK844691ENDOSCOPIC ASPIRATION CATHETER SETK842009ABDOMINAL PARACENTESIS TRAYK842001LIVER BIOPSY TRAYK841258FOREIGN BODY PROTECTORK840800POLYP-SAVER SLEVE

View all 9 devices →

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.

↑