SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES— 510(k) K983858
Substantially EquivalentSims Portex, Inc.
FDA 510(k) clearance K983858 for SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES, Substantially Equivalent on 1999-01-29. Applicant: Sims Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Portex, Inc.
- Product code
- Code MIA
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keene, NH, US
Recent devices under product code MIA
view all- K172800 — Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors
- K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
- K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
- K971645 — REGANES SPINAL NEEDLE (VARIOUS)
- K970997 — NEO-CARE LUMBER PUNCTURE KIT
More clearances from Sims Portex, Inc.
view all- K011925 — HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
- K002201 — ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
- K002506 — BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
- K001318 — CPAP SYSTEM, MODEL 102001
- K993619 — CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
Data sourced from openFDA. This site is unofficial and independent of the FDA.