CEBOPLANE
FDA 510(k) clearance K933933 · decided 1994-04-15
Clearance details
- K-number
- K933933
- Device name
- CEBOPLANE
- Applicant
- Synvasive Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-11
- Decision date
- 1994-04-15
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- HTZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rancho Cordova, CA, 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 |
|---|---|---|
| HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (K931737) | Synvasive Technology, Inc. | 1994-01-07 |
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| SIDE CUTTING SERRATED BLADE (K841980) | Stainless Mfg., Inc. | 1984-08-15 |
| CODMAN SUCTION PUNCH-PRODUCT CODES (K842774) | Codman & Shurtleff, Inc. | 1984-07-27 |
| ROSETTE KNIFE 4MM (K841975) | Stainless Mfg., Inc. | 1984-06-19 |
| LATERAL RELEASE KNIFE 5MM & 7MM (K841978) | Stainless Mfg., Inc. | 1984-06-19 |
| KOGAN ENDOSPECULUM 9-1/2 (K842111) | J. Sklar Mfg. Co., Inc. | 1984-06-19 |
| MENISCOTOME 4MM & 5MM (K841982) | Stainless Mfg., Inc. | 1984-06-19 |
| HOOK KNIFE 4MM & 5MM (K841976) | Stainless Mfg., Inc. | 1984-06-19 |
Recalls involving this device
No recalls on record reference this clearance.