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FDA 510(k)

SINGLE USE INSTRUMENT TRAY

K-Number: K962328 · 1996-08-09

ApplicantMedcare Medical Group, Inc.
Decision Date1996-08-09
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SINGLE USE INSTRUMENT TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Medical Group, Inc.. It received FDA 510(k) clearance on 1996-08-09 under 510(k) number K962328. 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 SINGLE USE INSTRUMENT TRAY?

SINGLE USE INSTRUMENT TRAY is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is Medcare Medical Group, Inc.. The 510(k) number is K962328.

When did SINGLE USE INSTRUMENT TRAY receive FDA 510(k) clearance?

SINGLE USE INSTRUMENT TRAY received FDA 510(k) clearance on 1996-08-09, under 510(k) number K962328.

Who is the listed applicant for SINGLE USE INSTRUMENT TRAY?

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

What is the FDA product code for SINGLE USE INSTRUMENT TRAY?

The FDA product code for SINGLE USE INSTRUMENT 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 Medcare Medical Group, 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.

K973497HUBERLOCK970152BIOPSY TRAYK962849CATHETER INSERTION TRAYK961075MEDCARE REGIONAL ANETHESIA KITK962527GENERAL PURPOSE DENTAL TRAYK961880MEDCARE SUCTION CONNECTING TUBING

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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.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.K912104MAJOR BASIN 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.

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