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 COUPLER

K-Number: K833483 · 1984-02-10

ApplicantMerrimack Laboratories
Decision Date1984-02-10
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC COUPLER is the device name listed in this FDA 510(k) record. The listed applicant is Merrimack Laboratories. It received FDA 510(k) clearance on 1984-02-10 under 510(k) number K833483. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC COUPLER?

ENDOSCOPIC COUPLER is a medical device that received FDA 510(k) clearance on 1984-02-10. The listed applicant is Merrimack Laboratories. The 510(k) number is K833483.

When did ENDOSCOPIC COUPLER receive FDA 510(k) clearance?

ENDOSCOPIC COUPLER received FDA 510(k) clearance on 1984-02-10, under 510(k) number K833483.

Who is the listed applicant for ENDOSCOPIC COUPLER?

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

What is the FDA product code for ENDOSCOPIC COUPLER?

The FDA product code for ENDOSCOPIC COUPLER is EOQ.

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 Merrimack Laboratories 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.

K833528CARBON DIOXIDE LASER ML 825K827963MODEL ML-850K827506MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERYK827442ML-810 CARBON DIOXIDE LASER SYSTEMK800227ML-800 CO2

Related Devices (Code: EOQ)

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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.

↑