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FDA 510(k)

GRADTECH SYRINGE SYSTEM

K-Number: K864732 · 1987-04-15

ApplicantGradtech
Decision Date1987-04-15
Product CodeEGM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GRADTECH SYRINGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gradtech. It received FDA 510(k) clearance on 1987-04-15 under 510(k) number K864732. 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 GRADTECH SYRINGE SYSTEM?

GRADTECH SYRINGE SYSTEM is a medical device that received FDA 510(k) clearance on 1987-04-15. The listed applicant is Gradtech. The 510(k) number is K864732.

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

GRADTECH SYRINGE SYSTEM received FDA 510(k) clearance on 1987-04-15, under 510(k) number K864732.

Who is the listed applicant for GRADTECH SYRINGE SYSTEM?

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

What is the FDA product code for GRADTECH SYRINGE SYSTEM?

The FDA product code for GRADTECH SYRINGE SYSTEM is EGM.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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