PolyCatch Retrieval Device
FDA 510(k) K142258 · Medi-Globe Corporation
510(k) numberK142258
Submission
- Device name
- PolyCatch Retrieval Device
- Applicant
- Medi-Globe Corporation
Tempe, AZ, US - Received
- August 14, 2014
- Decision date
- September 30, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was PolyCatch Retrieval Device cleared by the FDA?
PolyCatch Retrieval Device (K142258) received a 510(k) decision of Substantially Equivalent on September 30, 2014, 47 days after the submission was received.
What is the product code of K142258?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.