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)

MICRO ENDOSCOPIC ELECTRODE (ME2)

K-Number: K931281 · 1993-07-23

ApplicantCodman & Shurtleff, Inc.
Decision Date1993-07-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICRO ENDOSCOPIC ELECTRODE (ME2) is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1993-07-23 under 510(k) number K931281. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO ENDOSCOPIC ELECTRODE (ME2)?

MICRO ENDOSCOPIC ELECTRODE (ME2) is a medical device that received FDA 510(k) clearance on 1993-07-23. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K931281.

When did MICRO ENDOSCOPIC ELECTRODE (ME2) receive FDA 510(k) clearance?

MICRO ENDOSCOPIC ELECTRODE (ME2) received FDA 510(k) clearance on 1993-07-23, under 510(k) number K931281.

Who is the listed applicant for MICRO ENDOSCOPIC ELECTRODE (ME2)?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO ENDOSCOPIC ELECTRODE (ME2)?

The FDA product code for MICRO ENDOSCOPIC ELECTRODE (ME2) is GCJ.

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 Codman & Shurtleff, Inc. 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.

K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetK191237CERENOVUS Large Bore CatheterK173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitK172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagK172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)K171862GALAXY G3 Mini Microcoil Delivery System

View all 147 devices →

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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.

↑