DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
FDA 510(k) clearance K910254 · decided 1991-04-18
Clearance details
- K-number
- K910254
- Device name
- DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
- Applicant
- CooperSurgical, Inc.
- Decision
- Unknown
- Date received
- 1991-01-22
- Decision date
- 1991-04-18
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HHE
- Device class
- 2
- Regulation number
- 884.5400
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch CooperSurgical
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 |
|---|---|---|
| Sunny Cup and Applicator (K233361) | Menstrual Mates | 2024-06-21 |
| MELUNA CLASSIC/SPORT MENSTRUAL CUP (K140626) | Meluna | 2014-07-10 |
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |
| SCKOONCUP (K120107) | Sckoon, Inc. | 2012-09-18 |
| RHEA CUP (K112165) | Apex Medical Technologies, Inc. | 2012-05-24 |
| BELLECUP (K092985) | Librette, Inc. | 2010-06-28 |
| LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (K091754) | Lune Group , Ltd. | 2009-11-13 |
| ALICIA MENSTRUAL CUP (K070965) | Alicia International Pty , Ltd. | 2008-03-05 |
| MOONCUP (K060852) | Mooncup Limited | 2006-12-26 |
| MOONCUP, STYLE A & B (K040335) | Mooncup, LLC | 2005-03-30 |
| THE DIVACUP MENSTRUAL SOLUTION (K021356) | Diva International, Inc. | 2002-07-16 |
| INSTEAD, SOFTCUP (K971303) | Ultrafem, Inc. | 1997-06-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Mara Water Vapor Ablation System (P160047/S039) | CooperSurgical, Inc. | 2025-01-07 |
| MARA Water Vapor Ablation System (P160047/S035) | CooperSurgical, Inc. | 2024-07-11 |
| MARA Water Vapor Ablation System (P160047/S038) | CooperSurgical, Inc. | 2024-07-09 |
| MARA Water Vapor Ablation System (P160047/S036) | CooperSurgical, Inc. | 2024-05-10 |
| Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034) | CooperSurgical, Inc. | 2023-12-08 |
| MARA Water Vapor Ablation System (P160047/S033) | CooperSurgical, Inc. | 2023-10-25 |
| Mara Water Vapor Ablation System (P160047/S031) | CooperSurgical, Inc. | 2023-07-28 |
| Mara Water Vapor Ablation System (P160047/S032) | CooperSurgical, Inc. | 2023-07-27 |