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)

TUNGSTEN SYRINGE SHIELD

K-Number: K811688 · 1981-07-02

ApplicantMedi-Physics Inc. Dba Nycomed Amersham Imaging
Decision Date1981-07-02
Product CodeIWR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TUNGSTEN SYRINGE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Physics Inc. Dba Nycomed Amersham Imaging. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K811688. The device is classified under product code IWR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUNGSTEN SYRINGE SHIELD?

TUNGSTEN SYRINGE SHIELD is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Medi-Physics Inc. Dba Nycomed Amersham Imaging. The 510(k) number is K811688.

When did TUNGSTEN SYRINGE SHIELD receive FDA 510(k) clearance?

TUNGSTEN SYRINGE SHIELD received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811688.

Who is the listed applicant for TUNGSTEN SYRINGE SHIELD?

The FDA 510(k) record lists Medi-Physics Inc. Dba Nycomed Amersham Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUNGSTEN SYRINGE SHIELD?

The FDA product code for TUNGSTEN SYRINGE SHIELD is IWR.

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-Physics Inc. Dba Nycomed Amersham Imaging 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.

K010821ECHOSEED/IODINE-125 SEEDS, MODEL 6733K940632I-125 RAPID STRANDK921961SDMO APPLICATOR CODE: ASN.8236K915156I-125 SEEDS CODE: 6702K914281I-125 SEEDS, CODE: 6711K914268I-125 SEEDS IN CARRIER, CODE: 6720

View all 9 devices →

Related Devices (Code: IWR)

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.

K934549ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELDVictoreen, Inc.K872656LEAD GLASS SHIELDSViox Corp.K863936DUFFY BOLUS INJECTORViox Corp.

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.

↑