5 Star Medical Endoscope
FDA 510(k) K963354 · Five Star Medical, Inc.
510(k) numberK963354
Submission
- Device name
- 5 Star Medical Endoscope
- Applicant
- Five Star Medical, Inc.
Charlottesville, VA, US - Received
- August 26, 1996
- Decision date
- September 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODF – Mini Endoscope, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code ODF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092739 | Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light…ODF · Traditional | C-Link Micro Imaging, Inc. | 01/12/2010SE |
| K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…ODF · Traditional | Lumenis, Inc. | 09/30/2009SE |
| K090170 | Spyscope Access and Delivery CatheterODF · Traditional | Boston Scientific Corp | 02/04/2009SE |
| K052194 | Spyglass Direct Visualization Probe and OcularODF · Traditional | Boston Scientific Corp | 08/24/2005SE |
| K050403 | Spyglass Direct Visulation ProbeODF · Traditional | Boston Scientific Corp | 03/04/2005SE |
| K943593 | Saratoga Modular Miniature Endoscope SystemODF · Traditional | Ovamed Corp. | 03/22/1995SE |
| K941230 | Mini-Ub EndoscopesODF · Traditional | Candela Laser Corp. | 06/17/1994SE |
| K933106 | EndoscopeODF · Traditional | Origin Medsystems, Inc. | 10/19/1993SE |
| K912089 | Modified Series 2100 EndoscopesODF · Traditional | Medical Laser, Inc. | 08/12/1991SE |
| K910732 | Candela Mini-Ub EndoscopeODF · Traditional | Candela Laser Corp. | 04/12/1991SE |
More from Candela Laser Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K960876 | Five Star BronchoscopeEOB · Traditional | 05/08/1996SE |
Questions and answers
When was 5 Star Medical Endoscope cleared by the FDA?
5 Star Medical Endoscope (K963354) received a 510(k) decision of Substantially Equivalent on September 8, 1997, 378 days after the submission was received.
What is the product code of K963354?
The FDA product code is ODF – Mini Endoscope, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.