EASY LOOP, MODEL EZL-01
FDA 510(k) clearance K040110 · decided 2004-03-24
Clearance details
- K-number
- K040110
- Device name
- EASY LOOP, MODEL EZL-01
- Applicant
- Tools For Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-01-20
- Decision date
- 2004-03-24
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- EZP
- Device class
- 2
- Regulation number
- 876.4270
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stony Brook, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COLOPLAST OSTOMY ROD, MODEL 12814 (K052229) | Coloplast Corp. | 2006-10-13 |
Recalls involving this device
No recalls on record reference this clearance.