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FDA 510(k)

INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM

K-Number: K864861 · 1987-02-13

ApplicantInstrumentations Unltd.
Decision Date1987-02-13
Product CodeEGM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentations Unltd.. It received FDA 510(k) clearance on 1987-02-13 under 510(k) number K864861. The device is classified under product code EGM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM?

INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM is a medical device that received FDA 510(k) clearance on 1987-02-13. The listed applicant is Instrumentations Unltd.. The 510(k) number is K864861.

When did INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM receive FDA 510(k) clearance?

INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM received FDA 510(k) clearance on 1987-02-13, under 510(k) number K864861.

Who is the listed applicant for INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM?

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

What is the FDA product code for INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM?

The FDA product code for INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM is EGM.

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 Instrumentations Unltd. 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.

K910090DIMAC WIRES

Related Devices (Code: EGM)

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.

K243427QuickSleeper 5DentalhitecK083811W&H HANDPIECE ANESTO, MODEL: RA-5W&H Dentalwerk Buermoos GmbHK964802CYBERJET LOCAL ANESTHESIA SYSTEMIntra Vantage, Inc.K962017HYPODERMIC JET INJECTION APPARATUSAmerican Jet Injector Corp.K904279PAROJECT ANESTHETIC SYRINGERonvig Instruments, Ltd.K864294HENKE-JECT PRESSURE SYRINGE (MODIFICATION)Smith & Nephew, 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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