FDA 510(k)

INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)

K-Number: K101359 · 2010-08-20

Decision Date2010-08-20

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) is the device name listed in this FDA 510(k) record. The listed applicant is Inviro Medical Devices, Inc.. It received FDA 510(k) clearance on 2010-08-20 under 510(k) number K101359. 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 INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)?

INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) is a medical device that received FDA 510(k) clearance on 2010-08-20. The listed applicant is Inviro Medical Devices, Inc.. The 510(k) number is K101359.

When did INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) receive FDA 510(k) clearance?

INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) received FDA 510(k) clearance on 2010-08-20, under 510(k) number K101359.

Who is the listed applicant for INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)?

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

What is the FDA product code for INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)?

The FDA product code for INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) is FMF.

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Other records listing Inviro Medical Devices, Inc. as applicant

K0924301 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES K092413INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES K083851INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 K081436INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES K071307INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 K070203INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024

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Related Devices (Code: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-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, LLC K253110Sol-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.