Search Results
Found 2 results
510(k) Data Aggregation
K Number
K001594Device Name
3.5 MM LAPAROSCOPE (LG100, LG103)
Manufacturer
SURGICAL IMAGE LABORATORIES, INC.
Date Cleared
2000-06-12
(20 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL IMAGE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K955845Device Name
LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
Manufacturer
SURGICAL IMAGE LABORATORIES, INC.
Date Cleared
1996-07-05
(196 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL IMAGE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The Surgical Image Laboratories Laparoscope is equivalent in materials, intended use, safety and effectiveness to the Dyonics 8000 Laparoscope. The outer tube is fabricated from 304 stainless steel. The block and light adapter are made from plated brass and the I.D. ring from anodized aluminum. The distal end tip is fabricated from optical glass which may be coated with an anti-reflective coating. The optic tube which fits within the outer tube is fabricated from stainless steel. The distal fiber which transmits light from the light source through the fiber cone, around the optic tube, and on to the surgical area is fabricated from optical fibers and sealed at the distal end with adhesive. The eye shield or camera connection adapter is made from acetal plastic or an FDA accepted equivalent. All surfaces are smooth and polished or bead blasted. The end of the instrument that is inserted into the human body through an incision is blunt or rounded with no sharp edges.
Ask a Question
Page 1 of 1