510(k) K252140
K252140 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Heylo System". The FDA issued a decision of Substantially Equivalent on Oct 6, 2025. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 2025
- Date Received
- Jul 8, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Ostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type