Circon AEH-4 Electrohydraulic Lithotripsy Probe
FDA 510(k) K011848 · Circon Video
510(k) numberK011848
Submission
- Device name
- Circon AEH-4 Electrohydraulic Lithotripsy Probe
- Applicant
- Circon Video
Santa Barbara, CA, US - Received
- June 13, 2001
- Decision date
- September 11, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
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| K011849 | MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes…FGB · Traditional | 12/10/2001SE |
| K012929 | Flexible Pediatric Cystoureteroscope, Model Aur- 735FAJ · Traditional | 11/19/2001SE |
| K012951 | APN-2 USA Series Flexible CholedochoscopeFGB · Traditional | 11/09/2001SE |
| K012925 | DUR-8, Models DUR-8FGB · Traditional | 11/07/2001SE |
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| K012153 | Lowsley Suprapubic TractorKOB · Traditional | 09/19/2001SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | 10/24/1997SE |
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Questions and answers
When was Circon AEH-4 Electrohydraulic Lithotripsy Probe cleared by the FDA?
Circon AEH-4 Electrohydraulic Lithotripsy Probe (K011848) received a 510(k) decision of Substantially Equivalent on September 11, 2001, 90 days after the submission was received.
What is the product code of K011848?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.