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)

NUTIP (TM) SYRINGE SHIELD

K-Number: K911214 · 1991-07-17

ApplicantWestern M/D, Inc.
Decision Date1991-07-17
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUTIP (TM) SYRINGE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Western M/D, Inc.. It received FDA 510(k) clearance on 1991-07-17 under 510(k) number K911214. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUTIP (TM) SYRINGE SHIELD?

NUTIP (TM) SYRINGE SHIELD is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Western M/D, Inc.. The 510(k) number is K911214.

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

NUTIP (TM) SYRINGE SHIELD received FDA 510(k) clearance on 1991-07-17, under 510(k) number K911214.

Who is the listed applicant for NUTIP (TM) SYRINGE SHIELD?

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

What is the FDA product code for NUTIP (TM) SYRINGE SHIELD?

The FDA product code for NUTIP (TM) SYRINGE SHIELD is EKJ.

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 Western M/D, 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.

K931772SURETIP SYRINGE TIP COVER

Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, 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.

↑