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)

STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU

K-Number: K914694 · 1992-01-16

ApplicantDepuy, Inc.
Decision Date1992-01-16
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1992-01-16 under 510(k) number K914694. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU?

STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU is a medical device that received FDA 510(k) clearance on 1992-01-16. The listed applicant is Depuy, Inc.. The 510(k) number is K914694.

When did STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU receive FDA 510(k) clearance?

STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU received FDA 510(k) clearance on 1992-01-16, under 510(k) number K914694.

Who is the listed applicant for STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU?

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

What is the FDA product code for STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU?

The FDA product code for STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU is JCX.

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 Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

View all 303 devices →

Related Devices (Code: JCX)

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.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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.

↑