AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
FDA 510(k) clearance K980492 · decided 1998-11-17
Clearance details
- K-number
- K980492
- Device name
- AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
- Applicant
- Circon Acmi
- Decision
- Substantially Equivalent
- Date received
- 1998-02-09
- Decision date
- 1998-11-17
- Days to decision
- 281 days
- Clearance type
- Traditional
- Product code
- FFK
- Device class
- 2
- Regulation number
- 876.4480
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stamford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM recall (Z-0925-04) | ACMI CORPORATION | 2004-07-20 |
| ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM recall (Z-0926-04) | ACMI CORPORATION | 2004-07-20 |
| ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x 60CM recall (Z-0927-04) | ACMI CORPORATION | 2004-07-20 |
| ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM recall (Z-0928-04) | ACMI CORPORATION | 2004-07-20 |