SCUBA SYSTEM
FDA 510(k) clearance K962482 · decided 1996-11-01
Clearance details
- K-number
- K962482
- Device name
- SCUBA SYSTEM
- Applicant
- Gynecare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-26
- Decision date
- 1996-11-01
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US recall (Z-0493-05) | Ethicon, Inc | 2005-02-02 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S044) | Gynecare, Inc. | 2016-01-04 |
| GYNECARE THERMACHOICE II BALLOON CATHETER (P970021/S043) | Gynecare, Inc. | 2015-10-02 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S042) | Gynecare, Inc. | 2014-12-04 |
| GYNECARE THERMACHOICE UTERINE BALLON THERAPY SYSTEM (P970021/S041) | Gynecare, Inc. | 2014-04-09 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S040) | Gynecare, Inc. | 2014-03-17 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S039) | Gynecare, Inc. | 2014-02-24 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S038) | Gynecare, Inc. | 2013-06-20 |
| GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM (P970021/S037) | Gynecare, Inc. | 2013-04-03 |