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FDA 510(k)

ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD

K-Number: K972877 · 1998-02-26

ApplicantSafety Syringes, Inc.
Decision Date1998-02-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Safety Syringes, Inc.. It received FDA 510(k) clearance on 1998-02-26 under 510(k) number K972877. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD?

ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD is a medical device that received FDA 510(k) clearance on 1998-02-26. The listed applicant is Safety Syringes, Inc.. The 510(k) number is K972877.

When did ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD receive FDA 510(k) clearance?

ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD received FDA 510(k) clearance on 1998-02-26, under 510(k) number K972877.

Who is the listed applicant for ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD?

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

What is the FDA product code for ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD?

The FDA product code for ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD is FMF.

Related Clinical Trials

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Other records listing Safety Syringes, 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.

K123743ULTRASAFE PLUS PASSIVE NEEDLE GUARDK122558ULTRASAFE PASSIVE NEEDLE GUARDK060743MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)K042712TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEMK013801ULTRASAFE DENTAL INJECTION SYSTEMK011369ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)

View all 10 devices →

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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