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FDA 510(k)

PROCEDUR 10 SYRINGE DEVICE

K-Number: K042486 · 2005-01-21

ApplicantAvanca Medical Devices, Inc.
Decision Date2005-01-21
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROCEDUR 10 SYRINGE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Avanca Medical Devices, Inc.. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K042486. 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 PROCEDUR 10 SYRINGE DEVICE?

PROCEDUR 10 SYRINGE DEVICE is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Avanca Medical Devices, Inc.. The 510(k) number is K042486.

When did PROCEDUR 10 SYRINGE DEVICE receive FDA 510(k) clearance?

PROCEDUR 10 SYRINGE DEVICE received FDA 510(k) clearance on 2005-01-21, under 510(k) number K042486.

Who is the listed applicant for PROCEDUR 10 SYRINGE DEVICE?

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

What is the FDA product code for PROCEDUR 10 SYRINGE DEVICE?

The FDA product code for PROCEDUR 10 SYRINGE DEVICE is FMF.

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Other records listing Avanca Medical Devices, 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.

K052075PROCEDUR-10K042487PROCEDUR SF SAFETY SYRINGE DEVICE

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

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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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