Cleared Traditional

CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA

K982269 · Allegiance Healthcare Corp. · Anesthesiology
Jul 1998
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K982269 is an FDA 510(k) clearance for the CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA, a Needle, Spinal, Short Term (Class II — Special Controls, product code MIA), submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on July 23, 1998, 24 days after receiving the submission on June 29, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K982269 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1998
Decision Date July 23, 1998
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MIA — Needle, Spinal, Short Term
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

Similar Devices — MIA Needle, Spinal, Short Term

All 9
Portex? Lancet Point Spinal Needles with NRFit? connectors, Portex? Pencil Point Spinal Needles with NRFit? connectors
K172800 · Smiths Medical Asd, Inc. · Jun 2018
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
K051860 · Epimed International, Inc. · Aug 2005
SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
K983858 · Sims Portex, Inc. · Jan 1999
REGANES SPINAL NEEDLE (VARIOUS)
K971645 · Avid N.I.T., Inc. · Aug 1997
NEO-CARE LUMBER PUNCTURE KIT
K970997 · Klein-Baker Medical, Inc. · May 1997
GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES
K961324 · Global Medical Prods, Inc. · Jul 1996