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

SPINAL NEEDLE

K Number: K823692 · Decision Jan 7, 1983
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
9
Review Days
30

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Basic Information

Device Name
SPINAL NEEDLE
K Number
K823692
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5150
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Ocean Medical Products, Ltd.
Date Received
December 8, 1982
Decision Date
January 7, 1983
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 Ocean Medical Products, Ltd.

K Number Device Name
K882013 SOFT TISSUE BIOPSY DEVICE
K870896 NOTCH-NEEDLE, WESCOTT STYLE
K843719 SINGLE WALL INTRODUCER NEEDLE
K823693 MYELOGRAPHY NEEDLE
K813462 MADAYAG TYPE NEEDLE
K813448 POTTS-COURNAND STYLE NEEDLE
K813460 CHIBA SKINNY NEEDLE
K813461 PERCUTANEOUS ENTRY NEEDLE, SELDINGER