FDA 510(k)

INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES

K-Number: K081436 · 2008-10-22

Decision Date2008-10-22

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES 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 2008-10-22 under 510(k) number K081436. 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 3ML, 5ML, 10ML LUER LOCK SYRINGES?

INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES is a medical device that received FDA 510(k) clearance on 2008-10-22. The listed applicant is Inviro Medical Devices, Inc.. The 510(k) number is K081436.

When did INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES receive FDA 510(k) clearance?

INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES received FDA 510(k) clearance on 2008-10-22, under 510(k) number K081436.

Who is the listed applicant for INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES?

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 3ML, 5ML, 10ML LUER LOCK SYRINGES?

The FDA product code for INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES is FMF.

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Other records listing Inviro Medical Devices, Inc. as applicant

K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)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 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)

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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.