TRANSCERVICAL INTRAUTERINE KIT
FDA 510(k) clearance K914387 · decided 1991-12-30
Clearance details
- K-number
- K914387
- Device name
- TRANSCERVICAL INTRAUTERINE KIT
- Applicant
- Telos Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-01
- Decision date
- 1991-12-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HGS
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Keene, 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 |
|---|---|---|
| INTRAUTERINE CATHETER SET (K905812) | Epcom Medical Systems, Inc. | 1991-01-31 |
Recalls involving this device
No recalls on record reference this clearance.