Control-Tip Cystoscopic Electrodes
FDA 510(k) K903156 · North American Sterilization & Packaging Co.
510(k) numberK903156
Submission
- Device name
- Control-Tip Cystoscopic Electrodes
- Applicant
- North American Sterilization & Packaging Co.
Sparta, NJ, US - Received
- July 18, 1990
- Decision date
- December 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K962352 | Hydrogel Skin DressingNAE · Traditional | 08/02/1996SE |
| K925593 | Nortec Sterile Water for Device IrrigationLDQ · Traditional | 12/03/1993SE |
| K925588 | Nortec Ster SALINE-O.9% Sodium Chlor for Dev IrriLDQ · Traditional | 12/03/1993SE |
| K925161 | Nortec Sterile Water for Catheter Balloon InflatioKNY · Traditional | 07/21/1993SE |
| K911865 | Nortec Connecting Tube SetGAZ · Traditional | 11/01/1991SE |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 09/23/1991SE |
| K910691 | Nortec Ureteral StentFAD · Traditional | 08/15/1991SE |
| K903162 | Flexible Endoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
Questions and answers
When was Control-Tip Cystoscopic Electrodes cleared by the FDA?
Control-Tip Cystoscopic Electrodes (K903156) received a 510(k) decision of Substantially Equivalent on December 18, 1990, 153 days after the submission was received.
What is the product code of K903156?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.