SPECULITE
FDA 510(k) clearance K963391 · decided 1997-12-12
Clearance details
- K-number
- K963391
- Device name
- SPECULITE
- Applicant
- Trylon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-28
- Decision date
- 1997-12-12
- Days to decision
- 471 days
- Clearance type
- Traditional
- Product code
- MPU
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Monarch Beach, 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 |
|---|---|---|
| ORALLITE COMPREHENSIVE EXAM TRAY (K012070) | Trylon Corp. | 2001-11-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box. recall (Z-0977-03) | Watson Diagnostics Inc. | 2003-08-26 |