FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

NEEDLE/CANNULA

K Number: K950574 · Decision Feb 24, 1995
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
14
Review Days
28

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Basic Information

Device Name
NEEDLE/CANNULA
K Number
K950574
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4370
Medical Specialty
General, Plastic Surgery
Decision
Unknown
Statement or Summary
Statement
Applicant
Tri-Med Specialties, Inc.
Date Received
January 27, 1995
Decision Date
February 24, 1995
Product Code
LRO
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
LRO General Surgery Tray

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Other Clearances by Tri-Med Specialties, Inc.

K Number Device Name
K971615 PATTISON ESOPHAGEAL DILATOR
K970890 #ES-32 SUCTION CATHETER 32 FR.
K970982 T-RX RETRIEVAL FORCEPS
K942918 TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
K934348 TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR
K945160 PARACENTESIS NEEDLES/CANNULAS
K924549 TRI-MED QUICK-STEP(TM) RECTAL TUBE
K932015 TRI-MED INFLATABLE ESOPHAGEAL DILATOR
K932652 TRI-MED PARACENTESIS TRAY
K931201 TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
Search all 14 clearances from Tri-Med Specialties, Inc. →