DEGANIA SILICONE INDENTI LOOPS

K964547 · Degania Silicone , Ltd. · DXC · Jan 8, 1997 · Cardiovascular

Device Facts

• Record ID: K964547
• Device Name: DEGANIA SILICONE INDENTI LOOPS
• Applicant: Degania Silicone , Ltd.
• Product Code: DXC · Cardiovascular
• Decision Date: Jan 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended 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.

Device Story

Vascular ties/loops used for intraoperative identification, retraction, or occlusion of anatomical structures (tendons, ureters, nerves, arteries, veins). Device provides temporary surgical access/control. Operated by surgeons/surgical staff in OR setting. Available in Mini, Maxi, and Super Maxi sizes. No implantation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Silicone material. Vascular tie/loop form factor. Available in three sizes: Mini, Maxi, and Super Maxi. Non-implantable.

Indications for Use

Indicated for temporary intraoperative identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins during general surgical procedures. Not for implantation.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Degania Silicone Identi Loops (K964547)

Submission Summary (Full Text)

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180 9002

Degania Silicone

Degania Silicon Ltd.

Degania Bet 15130, Israel. Tel: [phone], Fax: [phone]

TUV

GMP

JAN 8 1997

K964547

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.

Bette Lubin
Product Advisor &
Regulatory Affairs
Degania Silicone

Nov. 11, 1996
Date

24/25