RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles— 510(k) K203668
Substantially EquivalentMyco Medical Supplies, Inc.
FDA 510(k) clearance K203668 for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles, Substantially Equivalent on 2021-09-29. Applicant: Myco Medical Supplies, Inc.. Device class: 2.
Clearance details
- Applicant
- Myco Medical Supplies, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Apex, NC, US
Recent devices under product code BSP
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view all- 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
- K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES
Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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.