Opus Smartstich Suture Device with Perfectpasser Connector
FDA 510(k) K062244 · Arthrocare Corp.
510(k) numberK062244
Submission
- Device name
- Opus Smartstich Suture Device with Perfectpasser Connector
- Applicant
- Arthrocare Corp.
San Juan Capistrano, CA, US - Received
- August 3, 2006
- Decision date
- October 2, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
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Questions and answers
When was Opus Smartstich Suture Device with Perfectpasser Connector cleared by the FDA?
Opus Smartstich Suture Device with Perfectpasser Connector (K062244) received a 510(k) decision of Substantially Equivalent on October 2, 2006, 60 days after the submission was received.
What is the product code of K062244?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.