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)

OPERATING ROOM TRAY SET

K-Number: K840021 · 1984-03-15

ApplicantMedi-Plast Intl., Inc.
Decision Date1984-03-15
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPERATING ROOM TRAY SET is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Plast Intl., Inc.. It received FDA 510(k) clearance on 1984-03-15 under 510(k) number K840021. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERATING ROOM TRAY SET?

OPERATING ROOM TRAY SET is a medical device that received FDA 510(k) clearance on 1984-03-15. The listed applicant is Medi-Plast Intl., Inc.. The 510(k) number is K840021.

When did OPERATING ROOM TRAY SET receive FDA 510(k) clearance?

OPERATING ROOM TRAY SET received FDA 510(k) clearance on 1984-03-15, under 510(k) number K840021.

Who is the listed applicant for OPERATING ROOM TRAY SET?

The FDA 510(k) record lists Medi-Plast Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPERATING ROOM TRAY SET?

The FDA product code for OPERATING ROOM TRAY SET is FSM.

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 Medi-Plast Intl., 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.

K954284MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)K87358810CC CONTROL SYRINGEK863402MEDI-PLAST DISPOSABLE MANIFOLDK861785FLUOROSCOPE BAND BAGK851489ARTERIAL-VENOUS COMPRESSION DRESSINGK842136STERILE PAN SET

View all 12 devices →

Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., 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.

↑