REPROCESSED DISPOSABLE TROCARS
FDA 510(k) clearance K013987 · decided 2002-03-01
Clearance details
- K-number
- K013987
- Device name
- REPROCESSED DISPOSABLE TROCARS
- Applicant
- Adven Medical
- Decision
- Substantially Equivalent
- Date received
- 2001-12-04
- Decision date
- 2002-03-01
- Days to decision
- 87 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
- Lubbock, TX, 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 TROCARS (K033591) | Clearmedical, Inc. | 2005-06-03 |
| 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.