HYSKON HYSTEROSCOPY FLUID
FDA premarket approval N17511/S014 · decided 2001-08-17
Approval details
- PMA number
- N17511
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYSKON HYSTEROSCOPY FLUID
- Generic name
- FLUID, HYSTEROSCOPY
- Applicant
- Coopervision Surgical
- Date received
- 2001-03-19
- Decision date
- 2001-08-17
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- LTA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR THE ADDITION OF A NEW WATER FOR INJECTION(WFI) GENERATION SYSTEM FOR THE WFI COMPONENT OF THE HYSKON(R) HYSTEROSCOPY FLUID.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| XENON LIGHT SOURCE AND ACCESSORIES (K921390) | Coopervision Surgical | 1992-07-27 |
| LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR (K905747) | Coopervision Surgical | 1991-09-17 |