FLEXIBLE ILLUMINATOR 15
FDA 510(k) clearance K840372 · decided 1984-04-24
Clearance details
- K-number
- K840372
- Device name
- FLEXIBLE ILLUMINATOR 15
- Applicant
- Suncoast Medical Manufacturers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-27
- Decision date
- 1984-04-24
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FTF
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| LITEPORT LP100 SURGICAL ILLUMINATOR (K041621) | Medical Vision Industries, Inc. | 2004-09-13 |
| FLEXIBLE ILLUMINATOR 10 (K840373) | Suncoast Medical Manufacturers, Inc. | 1984-04-24 |
| FLEXIBLE ILLUMINATOR 5 (K840371) | Suncoast Medical Manufacturers, Inc. | 1984-04-24 |
Recalls involving this device
No recalls on record reference this clearance.