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)

YAG LASER 8000 GASTROINTESTINAL BLEE

K-Number: K840144 · 1984-05-18

ApplicantCooper Medical Corp.
Decision Date1984-05-18
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

YAG LASER 8000 GASTROINTESTINAL BLEE is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Medical Corp.. It received FDA 510(k) clearance on 1984-05-18 under 510(k) number K840144. 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 YAG LASER 8000 GASTROINTESTINAL BLEE?

YAG LASER 8000 GASTROINTESTINAL BLEE is a medical device that received FDA 510(k) clearance on 1984-05-18. The listed applicant is Cooper Medical Corp.. The 510(k) number is K840144.

When did YAG LASER 8000 GASTROINTESTINAL BLEE receive FDA 510(k) clearance?

YAG LASER 8000 GASTROINTESTINAL BLEE received FDA 510(k) clearance on 1984-05-18, under 510(k) number K840144.

Who is the listed applicant for YAG LASER 8000 GASTROINTESTINAL BLEE?

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

What is the FDA product code for YAG LASER 8000 GASTROINTESTINAL BLEE?

The FDA product code for YAG LASER 8000 GASTROINTESTINAL BLEE 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 Cooper 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.

K833387ARGON LASER SURGICAL SYSTEM 770K833497COOPER MEDICAL MODEL 770K832703ARGON LASER SYS-MODEL 5000K820261MONITOR CO2 LASER SYSTEM

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.

↑