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

ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER

K Number: K860863 · Decision May 15, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
1
Review Days
69

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Basic Information

Device Name
ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER
K Number
K860863
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.4500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Applicant
George Percy Mcgown
Date Received
March 7, 1986
Decision Date
May 15, 1986
Product Code
LQC
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
LQC Lithotriptor, Biliary Mechanical

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