AMIELLE
FDA 510(k) clearance K983045 · decided 1998-11-25
Clearance details
- K-number
- K983045
- Device name
- AMIELLE
- Applicant
- Owen Mumford USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-01
- Decision date
- 1998-11-25
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KXP
- Device class
- 2
- Regulation number
- 884.3900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Allura Vaginal Stent (K202542) | Pmt Corporation | 2020-09-30 |
| SILIMED VAGINAL STENT (K974479) | Silimed, LLC | 1998-08-05 |
| PESSARY FLEXIBLE SILICONE NICHOLS (K920633) | Bioteque America, Inc. | 1995-11-08 |
Recalls involving this device
No recalls on record reference this clearance.