(56 days)
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation. Previously 2 sizes Mini and Maxi were available, we have now added Super Maxi (Extra Maxi).
This document is a 510(k) summary for the Degania Silicone Identi Loops, specifically addressing the addition of a "Super Maxi" size. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission for a new size of an existing device, emphasizing its substantial equivalence to previous versions, rather than new performance testing.
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Degania Silicone Ltd. Degania Bet 15130, Israel. Tel: 972-6-755712, Fax: 972-6-709182
8 1997 JAN
APPENDIX E
510(k) SUMMARY
Trade Name: Degania Silicone Identi Loops
Common Name: Vascular Ties or Loops
Product Code: 79
Device Class: I
Classification Panel: General & Plastic Surgery
Establishment Registration Number: 8030107
This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807:92.
DEVICE DESCRIPTION AND USE:
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.
Previously 2 sizes Mini and Maxi were available, we have now added Super Maxi (Extra Maxi).
MANUFACTURING :
The Identi Loops are manufactured from the same raw materials, from the same vendors and using the same manufacturing processes as our previous 510(k).
SUBSTANTIAL EQUIVALENCE:
We are Substantially Equivalent to ourselves.
Betty Lu
Nov. 11, 1896
Date
Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone
24/2
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).