LEEP REDIKIT
FDA 510(k) clearance K910253 · decided 1991-04-18
Clearance details
- K-number
- K910253
- Device name
- LEEP REDIKIT
- Applicant
- CooperSurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-22
- Decision date
- 1991-04-18
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HEE
- Device class
- 2
- Regulation number
- 884.5100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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| AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE (K000117) | Avid Medical, Inc. | 2000-04-13 |
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| ENDOCERVICAL BLOCK NEEDLE (K973671) | A & A Medical, Inc. | 1997-11-26 |
| ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE (K954718) | Ellman Intl., Inc. | 1996-02-29 |
| POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (K910252) | CooperSurgical, Inc. | 1991-03-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Ex recall (Z-0105-2016) | CooperSurgical, Inc. | 2015-10-06 |
| LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-vo recall (Z-1053-2013) | Cooper Surgical, Inc. | 2013-04-03 |
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 |