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)

MAJOR SET-UP TRAY

K-Number: K912159 · 1991-08-29

ApplicantMedical Device Inspection Co., Inc.
Decision Date1991-08-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAJOR SET-UP TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Inspection Co., Inc.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K912159. 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 MAJOR SET-UP TRAY?

MAJOR SET-UP TRAY is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Medical Device Inspection Co., Inc.. The 510(k) number is K912159.

When did MAJOR SET-UP TRAY receive FDA 510(k) clearance?

MAJOR SET-UP TRAY received FDA 510(k) clearance on 1991-08-29, under 510(k) number K912159.

Who is the listed applicant for MAJOR SET-UP TRAY?

The FDA 510(k) record lists Medical Device Inspection Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAJOR SET-UP TRAY?

The FDA product code for MAJOR SET-UP TRAY 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 Medical Device Inspection Co., 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.

K945826J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONSK932072JARIT SURGICAL INSTRUMENTSK931594THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEMK933580POWER WORK TABLEK933578POWERMATIC MAT PLATFORMK933581POWERMATIC TREATMENT TABLE

View all 30 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.

↑