Galileo Endoscopes
FDA 510(k) K934649 · Galileo Electro-Optics Corp.
510(k) numberK934649
Submission
- Device name
- Galileo Endoscopes
- Applicant
- Galileo Electro-Optics Corp.
Sturbridge, MA, US - Received
- September 29, 1993
- Decision date
- October 13, 1994
- 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 |
|---|---|---|
| K981928 | Galileo Disposable EndoscopesGCJ · Traditional | 08/06/1998SE |
| K962256 | Galileo Hysteroscopes and LaparoscopesHIH · Traditional | 12/06/1996SE |
| K962116 | Galileo EndoscopesEOB · Traditional | 11/27/1996SE |
| K934707 | Galileo ArthroscopesHRX · Traditional | 10/07/1994SE |
| K936280 | Galileo ArthroscopesHRX · Traditional | 07/12/1994SE |
| K936279 | Galileo EndoscopesGCJ · Traditional | 05/16/1994SE |
Questions and answers
When was Galileo Endoscopes cleared by the FDA?
Galileo Endoscopes (K934649) received a 510(k) decision of Substantially Equivalent on October 13, 1994, 379 days after the submission was received.
What is the product code of K934649?
The FDA product code is FBO – Cystourethroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.