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

ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB

K Number: K091930 · Decision Sep 23, 2009
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
7
Review Days
85

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Basic Information

Device Name
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB
K Number
K091930
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Anchor Products Co.
Date Received
June 30, 2009
Decision Date
September 23, 2009
Product Code
GCJ
Advisory Committee
Gastroenterology, Urology
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
GCJ Laparoscope, General & Plastic Surgery

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