CONCEPT SUCTION SLEEVE
FDA 510(k) clearance K850423 · decided 1985-03-14
Clearance details
- K-number
- K850423
- Device name
- CONCEPT SUCTION SLEEVE
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-04
- Decision date
- 1985-03-14
- Days to decision
- 38 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
- Clearwater, FL, 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 |
|---|---|---|
| CEBOPLANE (K933933) | Synvasive Technology, Inc. | 1994-04-15 |
| HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (K931737) | Synvasive Technology, Inc. | 1994-01-07 |
| 45 DEGREE SHAVER (K870882) | Bowen & Company, Inc. | 1987-03-23 |
| KAMBIN SPINAL INSTRUMENT SET (K853678) | Pilling Co. | 1985-09-24 |
| ARTHROSCOPY SUCTION BIOPSY PUNCH (K850527) | T. Korossurgical Instruments Corp. | 1985-03-14 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |