Opus SmartStitch Suture Device

• 2 recalls, same reason

  • Terminated Z-0612-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011 ·via K070671, on the same 510(k)
  • Terminated Z-0613-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011 ·via K070671, on the same 510(k)

  Product is being removed from the field due to an over-label issue.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K070671 ↗

FDA Product Code

OCW

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Opus SmartStitch Suture Device used for?

  The Opus SmartStitch Suture Device is designed for endoscopic or minimally invasive procedures to approximate soft tissue. It allows clinicians to place simple or mattress sutures using braided polyester or polyethylene sutures, making it ideal for confined surgical environments in gastroenterology and urology. Its manual operation and precise design help achieve accurate tissue alignment where visibility is limited.

• Is the Opus SmartStitch Suture Device single-use or reusable?

  The Opus SmartStitch Suture Device is intended for single-use applications only. This ensures sterility and reduces the risk of cross-contamination between patients. After use, the device should be discarded according to standard medical waste protocols.

• What types of sutures can be used with the Opus SmartStitch?

  The device is compatible with braided polyester or polyethylene sutures. These materials are chosen for their strength and flexibility, which are particularly useful in endoscopic procedures where precision and durability are critical. The device’s design accommodates these suture types to facilitate smooth placement and secure tissue approximation.

• How should the Opus SmartStitch Suture Device be stored?

  The Opus SmartStitch Suture Device is supplied sterile, so it must be stored in accordance with the manufacturer’s guidelines for sterile instruments. This typically involves keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Proper storage ensures the device remains uncontaminated and ready for use when needed.

• Can the Opus SmartStitch Suture Device be used in MRI environments?

  No, the Opus SmartStitch Suture Device is not MRI-compatible. This means it should not be used in or near MRI machines, as the magnetic fields could potentially affect the device’s performance or integrity. Clinicians should verify the device’s placement and ensure it is removed before any MRI procedure involving the patient.