510(k) K040110
K040110 is an FDA 510(k) premarket notification submitted by Tools For Surgery, LLC for the device "EASY LOOP, MODEL EZL-01". The FDA issued a decision of Substantially Equivalent on March 24, 2004. The device falls under product code EZP (Rod, Colostomy), a Class II device regulated under 21 CFR 876.4270. Tools For Surgery, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2004
- Date Received
- January 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Colostomy
- Device Class
- Class II
- Regulation Number
- 876.4270
- Review Panel
- GU
- Submission Type