Entuit PEG, Entuit PEGJ
FDA 510(k) K213356 · Wilson-Cook Medical, Inc.
510(k) numberK213356
Submission
- Device name
- Entuit PEG, Entuit PEGJ
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- October 12, 2021
- Decision date
- January 20, 2022
- Decision
- Unknown (SESD)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PIF – Gastrointestinal Tubes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
To facilitate enteral specific connections.
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Questions and answers
When was Entuit PEG, Entuit PEGJ cleared by the FDA?
Entuit PEG, Entuit PEGJ (K213356) received a 510(k) decision of Unknown on January 20, 2022, 100 days after the submission was received.
What is the product code of K213356?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.