SILIMED VAGINAL STENT
FDA 510(k) clearance K974479 · decided 1998-08-05
Clearance details
- K-number
- K974479
- Device name
- SILIMED VAGINAL STENT
- Applicant
- Silimed, LLC
- Decision
- Substantially Equivalent
- Date received
- 1997-11-26
- Decision date
- 1998-08-05
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- KXP
- Device class
- 2
- Regulation number
- 884.3900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Silimed
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 |
|---|---|---|
| Allura Vaginal Stent (K202542) | Pmt Corporation | 2020-09-30 |
| AMIELLE (K983045) | Owen Mumford USA, Inc. | 1998-11-25 |
| PESSARY FLEXIBLE SILICONE NICHOLS (K920633) | Bioteque America, Inc. | 1995-11-08 |
Recalls involving this device
No recalls on record reference this clearance.