SPECULUM, VAGINAL, METAL FIBEROPTIC
FDA 510(k) clearance K864865 · decided 1987-01-09
Clearance details
- K-number
- K864865
- Device name
- SPECULUM, VAGINAL, METAL FIBEROPTIC
- Applicant
- Luxtec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-11
- Decision date
- 1987-01-09
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- HDG
- Device class
- 1
- Regulation number
- 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Sturbridge, MA, 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 |
|---|---|---|
| VAGINAL ILLUMINATOR, MODEL 78570 (K771181) | Welch Allyn, Inc. | 1977-07-14 |
Recalls involving this device
No recalls on record reference this clearance.