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)

REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION

K-Number: K952395 · 1995-08-15

ApplicantContour Fabricators of Florida, Inc.
Decision Date1995-08-15
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Contour Fabricators of Florida, Inc.. It received FDA 510(k) clearance on 1995-08-15 under 510(k) number K952395. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION?

REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Contour Fabricators of Florida, Inc.. The 510(k) number is K952395.

When did REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION receive FDA 510(k) clearance?

REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION received FDA 510(k) clearance on 1995-08-15, under 510(k) number K952395.

Who is the listed applicant for REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION?

The FDA 510(k) record lists Contour Fabricators of Florida, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION?

The FDA product code for REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION is BSY.

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 Contour Fabricators of Florida, 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.

K955685RNS STERILE, DISPOSABLE CT BIOPSY TRAYK962040RNS ARTHROGRAM TRAYK955687RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAYK955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYK955684RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAYK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY

View all 18 devices →

Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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.

↑