RAYLOR FUSION FUNNEL
FDA 510(k) clearance K872281 · decided 1987-11-02
Clearance details
- K-number
- K872281
- Device name
- RAYLOR FUSION FUNNEL
- Applicant
- Cedar Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-16
- Decision date
- 1987-11-02
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- HXR
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minnetonka, MN, 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 |
|---|---|---|
| MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 (K983882) | Micro-Medical Devices, Inc. | 1999-03-15 |
| VIDEO ARTHROSCOPE, 1.7MM X 55 MM (K873387) | Arthropedics, Inc. | 1987-11-25 |
| H-H HUNTER PASSIVE TENDON IMPLANT (K853436) | Holter-Hausner Intl. | 1985-10-16 |
Recalls involving this device
No recalls on record reference this clearance.