Myco Medical Supplies Inc
Apex, NC, US
MYCO MEDICAL SUPPLIES, INC. appears in FDA device records in Apex, NC. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Myco Medical Supplies Inc between 1995 and 2021. The busiest year on record is 1999, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles | BSP | Substantially Equivalent | |
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | FMI | Substantially Equivalent | |
| K090426 | VAKU-8 BLOOD COLLECTION NEEDLES | FMI | Substantially Equivalent | |
| K042504 | CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER | FOZ | Substantially Equivalent | |
| K000592 | UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET | FPA | Substantially Equivalent | |
| K990519 | PHOENIX EPIDURAL & SPINAL NEEDLES | BSP | Substantially Equivalent | |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | GAL | Substantially Equivalent | |
| K990388 | TUTOPLUS IV ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K982098 | TUTODROP 1 AND TUTODROP 2 | FPA | Substantially Equivalent | |
| K963364 | GLASS VAN GLASS SYRINGES | FMF | Substantially Equivalent | |
| K953252 | DISPOSABLE SCALP VEIN INFUSION SET | FOZ | Substantially Equivalent | |
| K945225 | DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1058382 | 1000158634 | MYCO MEDICAL SUPPLIES, INC. | 2015 Production Drive, Apex, NC 27539 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0444-2016 | Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle | Particulates: Complaints of rubber coring from the closure of injection vials. | Class II | Terminated | |
| Z-0891-2013 | Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical. | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain