The VersaJet II Hydrosurgery System
FDA 510(k) K143115 · Smith & Nephew, Inc.
510(k) numberK143115
Submission
- Device name
- The VersaJet II Hydrosurgery System
- Applicant
- Smith & Nephew, Inc.
St Petersburg, FL, US - Received
- October 30, 2014
- Decision date
- July 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
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Questions and answers
When was The VersaJet II Hydrosurgery System cleared by the FDA?
The VersaJet II Hydrosurgery System (K143115) received a 510(k) decision of Substantially Equivalent on July 15, 2015, 258 days after the submission was received.
What is the product code of K143115?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.