Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories
FDA 510(k) K061646 · Laserscope
510(k) numberK061646
Submission
- Device name
- Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories
- Applicant
- Laserscope
San Jose, CA, US - Received
- June 12, 2006
- Decision date
- June 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
More from Surgical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062719 | Greenlight HPS Series Surgical Laser System & AccessoriesGEX · Traditional | 12/01/2006SE |
| K034011 | Gemini Surgical Laser System & AccessoriesGEX · Traditional | 03/30/2004SE |
| K024206 | Aura Isurgical Laser System & AccessoriesGEX · Traditional | 11/17/2003SE |
| K020021 | Lyra Surgical Laser System and Accessiories (Nd:Yag Configuration)GEX · Traditional | 07/02/2002SE |
| K010834 | Lyra Series Surgical Laser System & AccessoriesGEX · Traditional | 05/21/2001SE |
| K010284 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 05/01/2001SE |
| K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 03/06/2001SE |
| K003147 | Lyra Series Surgical Laser System (SL Series, Nd:Yag Configuration)GEX · Traditional | 12/15/2000SE |
| K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched Nd:Yag Configuration)GEX · Traditional | 03/08/2000SE |
| K990903 | Lyra Series Surgical System (SL Seriesq-Switched Nd:Yag Configuration)GEX · Traditional | 08/27/1999SE |
Questions and answers
When was Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories cleared by the FDA?
Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories (K061646) received a 510(k) decision of Substantially Equivalent on June 27, 2006, 15 days after the submission was received.
What is the product code of K061646?
The FDA product code is FBO – Cystourethroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.