INTRAUTERINE HEMOSTASIS BALLOON STENT
FDA 510(k) clearance K863439 · decided 1987-06-02
Clearance details
- K-number
- K863439
- Device name
- INTRAUTERINE HEMOSTASIS BALLOON STENT
- Applicant
- Mentor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-05
- Decision date
- 1987-06-02
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- KNA
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mentor Corp.
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 |
|---|---|---|
| PANPAC WORD/BARTHOLIN CATHETER (K130087) | Panpac Medical Corporation | 2014-01-10 |
| COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (K102141) | Cook Urological, Inc. | 2011-05-06 |
| GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (K093904) | Glenveigh Surgical, LLC | 2010-04-14 |
| COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (K082939) | Cook Urological, Inc. | 2009-09-03 |
| BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (K062438) | Cook Ob/Gyn | 2006-10-27 |
| EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (K060289) | Frontline Medical | 2006-07-07 |
| TAMPONADE UTERINE BALLOON CATHETER SET (K013597) | Cook Ob/Gyn | 2002-04-17 |
| DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (K014248) | Urogyn , Ltd. | 2002-03-21 |
| DND 101 (K001590) | Urogyn , Ltd. | 2000-08-02 |
| DR. JAHANGER'S CUTTER (K990738) | M.S. Jahanger, MD | 1999-10-29 |
| BERACLAMP, MODEL BC-1 (K990045) | Poamax LLC | 1999-05-24 |
| SCC-23 SAFETY CLAMP AND CUTTER (K982464) | Women First Healthcare, Inc. | 1998-08-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S084) | Mentor Corp. | 2025-12-17 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S080) | Mentor Corp. | 2025-08-12 |
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S082) | Mentor Corp. | 2025-08-08 |
| Mentor MemoryGel® Breast Implants (P030053/S072) | Mentor Corp. | 2025-08-06 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S077) | Mentor Corp. | 2025-07-03 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S081) | Mentor Corp. | 2025-06-18 |
| MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S079) | Mentor Corp. | 2025-05-21 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S078) | Mentor Corp. | 2025-02-14 |