REPROCESSED TROCARS
FDA 510(k) clearance K033591 · decided 2005-06-03
Clearance details
- K-number
- K033591
- Device name
- REPROCESSED TROCARS
- Applicant
- Clearmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-13
- Decision date
- 2005-06-03
- Days to decision
- 568 days
- Clearance type
- Traditional
- Product code
- KBG
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bellevue, WA, 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 |
|---|---|---|
| REPROCESSED DISPOSABLE TROCARS (K013987) | Adven Medical | 2002-03-01 |
| CONTINENT STOMA SYSTEM & ACCESSORIES (K844186) | Chesebrough-Pond'S U.S.A. Co. | 1985-01-15 |
Recalls involving this device
No recalls on record reference this clearance.