HSG TRAY
FDA 510(k) clearance K920803 · decided 1992-10-19
Clearance details
- K-number
- K920803
- Device name
- HSG TRAY
- Applicant
- Unimar, Inc.
- Decision
- Unknown
- Date received
- 1992-02-21
- Decision date
- 1992-10-19
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- HIB
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Wilton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpi recall (Z-2135-2025) | CooperSurgical, Inc. | 2025-07-18 |
| Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit recall (Z-2136-2025) | CooperSurgical, Inc. | 2025-07-18 |
| Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Conv recall (Z-2137-2025) | CooperSurgical, Inc. | 2025-07-18 |