Product code MUM— General, Plastic Surgery
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
- Classification name
- Stent, Metallic, Expandable, Duodenal
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 6
- First cleared
- Most recent
Market context for product code MUM
FDA has cleared devices under product code MUM between 1998 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
- 2017
- 2011
- 2006
- 1998
Top applicants under product code MUM
Adverse events under product code MUM
product code MUM- Death
- 6
- Injury
- 137
- Total
- 143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MUM
- K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
- K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
- K163468 — Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
- K101530 — EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
- K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
- K980113 — WALLSTENT ENTERAL ENDOPROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.