Phasix Mesh
FDA 510(k) K161424 · C.R. Bard, Inc.
510(k) numberK161424
Submission
- Device name
- Phasix Mesh
- Applicant
- C.R. Bard, Inc.
Warwick, RI, US - Received
- May 23, 2016
- Decision date
- September 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOD – Surgical Film
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
- Life-sustaining
- Yes
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical…
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Questions and answers
When was Phasix Mesh cleared by the FDA?
Phasix Mesh (K161424) received a 510(k) decision of Substantially Equivalent on September 29, 2016, 129 days after the submission was received.
What is the product code of K161424?
The FDA product code is OOD – Surgical Film, a Class II (moderate risk) device regulated under 21 CFR 878.3300.