Flexible Cmos-Video-Cysto-Urethroscope
FDA 510(k) K131364 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK131364
Submission
- Device name
- Flexible Cmos-Video-Cysto-Urethroscope
- Applicant
- KARL STORZ Endoscopy-America, Inc.
El Segundo, CA, US - Received
- May 13, 2013
- Decision date
- January 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBO – Cystourethroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope…FBO · Traditional | Karl Storz SE & CO. KG | 05/02/2025SE |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)FBO · Special | Karl Storz SE & CO. KG | 11/27/2024SE |
| K082046 | Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/ACUI and Circon…FBO · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/10/2008SE |
| K080780 | Anchorage Scope, Model 000003FBO · Traditional | Epitek, Inc. | 07/30/2008SE |
| K062918 | Karl Storz Flexible Video-Urethro-Cystoscope SystemFBO · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/17/2007SE |
| K061646 | Laserscope Guided Delivery Device (GDD) Cystourethroscope & AccessoriesFBO · Traditional | Laserscope | 06/27/2006SE |
| K011496 | Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…FBO · Traditional | Richard Wolf Medical Instruments Corp. | 08/10/2001SE |
| K972979 | Smith & Nephew Images Cystourethroscopes and Accessories, Smith & Nephew SEMI0RIGID and…FBO · Traditional | Smith & Nephew, Inc. | 12/11/1997SE |
| K962474 | Olympus FG Series of Rat Tooth Grasping Forceps (Urology)FBO · Traditional | Olympus America, Inc. | 12/20/1996SE |
| K941992 | CystoscopeFBO · Traditional | Surgical Technologies, Inc. | 11/30/1995SE |
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
Questions and answers
When was Flexible Cmos-Video-Cysto-Urethroscope cleared by the FDA?
Flexible Cmos-Video-Cysto-Urethroscope (K131364) received a 510(k) decision of Substantially Equivalent on January 2, 2014, 234 days after the submission was received.
What is the product code of K131364?
The FDA product code is FBO – Cystourethroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.