SHANGRING
FDA 510(k) clearance K131373 · decided 2013-06-25
Clearance details
- K-number
- K131373
- Device name
- SHANGRING
- Applicant
- Wuhu Snnda Medical Treatment Appliance Technology
- Decision
- Substantially Equivalent
- Date received
- 2013-05-13
- Decision date
- 2013-06-25
- Days to decision
- 43 days
- Clearance type
- Special
- Product code
- HFX
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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| PREPEX SYSTEM (K103695) | Circ Medtech | 2012-01-10 |
| MEDICON MOGEN CLAMP (K100916) | Medicon EG | 2010-12-06 |
| GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (K061539) | Clinical Innovations, LLC | 2007-09-20 |
| GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (K063429) | Generic Medical Device, Inc. | 2007-01-17 |
| SURGICAL DESIGN CIRCUMCISION CLAMP (K043533) | Surgical Design, Inc. | 2005-04-01 |
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Recalls involving this device
No recalls on record reference this clearance.