INTRAUTERINE CATHETER SET
FDA 510(k) clearance K905812 · decided 1991-01-31
Clearance details
- K-number
- K905812
- Device name
- INTRAUTERINE CATHETER SET
- Applicant
- Epcom Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-28
- Decision date
- 1991-01-31
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- HGS
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Livermore, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Epcom Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRANSCERVICAL INTRAUTERINE KIT (K914387) | Telos Medical Corp. | 1991-12-30 |
Recalls involving this device
No recalls on record reference this clearance.