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)

MSI SURGI-GRADE UNIVERSAL TRACH TRAY

K-Number: K843561 · 1984-10-24

ApplicantMedical Sterilization, Inc.
Decision Date1984-10-24
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MSI SURGI-GRADE UNIVERSAL TRACH TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Sterilization, Inc.. It received FDA 510(k) clearance on 1984-10-24 under 510(k) number K843561. 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 MSI SURGI-GRADE UNIVERSAL TRACH TRAY?

MSI SURGI-GRADE UNIVERSAL TRACH TRAY is a medical device that received FDA 510(k) clearance on 1984-10-24. The listed applicant is Medical Sterilization, Inc.. The 510(k) number is K843561.

When did MSI SURGI-GRADE UNIVERSAL TRACH TRAY receive FDA 510(k) clearance?

MSI SURGI-GRADE UNIVERSAL TRACH TRAY received FDA 510(k) clearance on 1984-10-24, under 510(k) number K843561.

Who is the listed applicant for MSI SURGI-GRADE UNIVERSAL TRACH TRAY?

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

What is the FDA product code for MSI SURGI-GRADE UNIVERSAL TRACH TRAY?

The FDA product code for MSI SURGI-GRADE UNIVERSAL TRACH TRAY 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 Medical Sterilization, 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.

K984422STERILE BACK SURGICAL GOWN WITH HAND TOWELK912803MSI STERILE BACK SURGICAL GOWN PACK HAND TOWELK843564MSI SURGI-GRADE SUTURE TRAYK843562MSI SURGI-GRADE DELUXE CUT-DOWN TRAYK843563MSI SURGI-GRADE INCISION & DRAIN TRAY

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.

↑