Home / 510(k) Clearances / K203668

510(k) K203668

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles by Myco Medical Supplies, Inc. — Product Code BSP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 29, 2021
Date Received: December 16, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class: Class II
Regulation Number: 868.5150
Review Panel: AN
Submission Type

Other clearances by Myco Medical Supplies, Inc.

K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (May 14, 2018)
K090426 — VAKU-8 BLOOD COLLECTION NEEDLES (June 12, 2009)
K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER (January 19, 2006)
K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET (April 12, 2001)
K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES (June 2, 2000)
K982646 — AILEE SUTURES AND AILEE NEEDLES (June 2, 1999)
K990388 — TUTOPLUS IV ADMINISTRATION SET (March 29, 1999)
K982098 — TUTODROP 1 AND TUTODROP 2 (March 1, 1999)
K963364 — GLASS VAN GLASS SYRINGES (May 1, 1998)
K953252 — DISPOSABLE SCALP VEIN INFUSION SET (November 26, 1996)

Other clearances for product code BSP

K243690 — SonoMSK (July 1, 2025)
K243682 — SonoPlex STIM; SonoPlex II (June 27, 2025)
K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (June 25, 2025)
K243525 — SonoTAP and SonoTAP II (March 24, 2025)
K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (November 22, 2024)
K241954 — SonoBlock; SonoBlock II (September 11, 2024)
K240253 — Reach Needle (March 21, 2024)
K212982 — Medispine - Spinal Needle, Glospine - Spinal Needle (July 29, 2022)
K211085 — BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (July 1, 2022)
K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (December 22, 2021)