FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

QUINCKE SPINAL NEEDLE

K Number: K022029 · Decision Jul 30, 2002
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
14
Review Days
39

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Basic Information

Device Name
QUINCKE SPINAL NEEDLE
K Number
K022029
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5150
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Epimed International, Inc.
Date Received
June 21, 2002
Decision Date
July 30, 2002
Product Code
BSP
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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Other Clearances by Epimed International, Inc.

K Number Device Name
K200624 Percutaneous Introducer
K190256 Rulo Radiofrequency Lesion Probe
K133316 SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
K053318 RX EPIDURAL NEEDLE
K051171 STINGRAY EPIDURAL CATHETER CONNECTOR
K051860 FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
K043467 FLEXIBLE SPINAL NEEDLE
K041021 RF INTRODUCTION CANNULA
K041843 PENCIL POINT NEEDLE
K023140 VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
Search all 14 clearances from Epimed International, Inc. →