Inviro Medical Devices, Inc.
Duluth, GA, US
Inviro Medical Devices, Inc. appears in FDA device records in Duluth, GA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Inviro Medical Devices, Inc. between 2007 and 2010. The busiest year on record is 2009, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101359 | INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) | FMF | Substantially Equivalent | |
| K092430 | 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES | MEG | Substantially Equivalent | |
| K092413 | INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES | MEG | Substantially Equivalent | |
| K083851 | INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 | LHI | Substantially Equivalent | |
| K081436 | INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES | FMF | Substantially Equivalent | |
| K071307 | INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 | FMI | Substantially Equivalent | |
| K070203 | INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 | MEG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1800-2010 | InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA. | Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain