AILEE SUTURES AND AILEE NEEDLES— 510(k) K982646
Substantially EquivalentMyco Medical Supplies, Inc.
FDA 510(k) clearance K982646 for AILEE SUTURES AND AILEE NEEDLES, Substantially Equivalent on 1999-06-02. Applicant: Myco Medical Supplies, Inc.. Device class: 2.
Clearance details
- Applicant
- Myco Medical Supplies, Inc.
- Product code
- Code GAL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4830
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cary, NC, US
Recent devices under product code GAL
view allMore clearances from Myco Medical Supplies, Inc.
view all- K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
- K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
- K090426 — VAKU-8 BLOOD COLLECTION NEEDLES
- K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
- K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
Adverse events under product code GAL
product code GAL- Malfunction
- 681
- Other
- 1
- Total
- 682
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.