Cystoscope
FDA 510(k) K941992 · Surgical Technologies, Inc.
510(k) numberK941992
Submission
- Device name
- Cystoscope
- Applicant
- Surgical Technologies, Inc.
Miami Lakes, FL, US - Received
- April 25, 1994
- Decision date
- November 30, 1995
- 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 |
| K131364 | Flexible Cmos-Video-Cysto-UrethroscopeFBO · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/02/2014SE |
| 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 |
More from Olympus America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942029 | ArthroscopeHRX · Traditional | 11/08/1995SE |
| K946136 | Infinitech Lighted Infusion CannulaMPA · Traditional | 10/02/1995SE |
| K952566 | OscilflatorMAV · Traditional | 08/31/1995SE |
| K951918 | Surgical Technologies, Inc. SyringeFMF · Traditional | 07/20/1995SE |
| K950683 | Arthrogram TrayJAA · Traditional | 05/06/1995SE |
| K946135 | Infinitech Aspirating Laser ProbeHQE · Traditional | 04/18/1995SE |
| K946181 | Infinitech Soft Tip Flute NeedleHQE · Traditional | 03/14/1995SE |
| K942030 | Biopsy ScissorsOCZ · Traditional | 06/27/1994SE |
| K942482 | Pressure Monitoring ExtensionDQO · Traditional | 06/14/1994SE |
| K941161 | Flexible Grasping ForcepsEOQ · Traditional | 05/04/1994SE |
Questions and answers
When was Cystoscope cleared by the FDA?
Cystoscope (K941992) received a 510(k) decision of Substantially Equivalent on November 30, 1995, 584 days after the submission was received.
What is the product code of K941992?
The FDA product code is FBO – Cystourethroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.