HYSKON HYSTEROSCOPY FLUID
FDA premarket approval N17511/S013 · decided 2000-02-09
Approval details
- PMA number
- N17511
- Supplement
- S013
- Supplement type
- 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
- 2000-01-10
- Decision date
- 2000-02-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LTA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- The 30-day notice reqeusted the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility for the device.
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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 |