Endoscope
FDA 510(k) K933106 · Origin Medsystems, Inc.
510(k) numberK933106
Submission
- Device name
- Endoscope
- Applicant
- Origin Medsystems, Inc.
Menlo Park, CA, US - Received
- June 25, 1993
- Decision date
- October 19, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K963354 | 5 Star Medical EndoscopeODF · Traditional | Five Star Medical, Inc. | 09/08/1997SE |
| K943593 | Saratoga Modular Miniature Endoscope SystemODF · Traditional | Ovamed Corp. | 03/22/1995SE |
| K941230 | Mini-Ub EndoscopesODF · Traditional | Candela Laser Corp. | 06/17/1994SE |
| 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 |
|---|---|---|
| K992353 | Blunt Tip Trocar PortGCJ · Traditional | 07/30/1999SE |
| K981700 | Vasoview Dissection/Vessel Harvesting SystemGCJ · Special | 05/29/1998SE |
| K972685 | Origin Ligator DeviceGCJ · Traditional | 10/01/1997SE |
| K970611 | Origin Cardiac Stablizer OccluderDXC · Traditional | 08/19/1997SE |
| K965121 | CannulaHET · Traditional | 03/20/1997SE |
| K964171 | Vasoview Balloon Dissection SystemGCJ · Traditional | 02/14/1997SE |
| K962104 | Airlift Balloon Retracton SystemGCJ · Traditional | 09/11/1996SE |
| K962005 | Extrahand Balloon RetractorGCJ · Traditional | 08/12/1996SE |
| K960936 | Resposable Trocar System [5MM, 5MM Short, 10MM and 12MM Sizes]HET · Traditional | 07/24/1996SE |
| K960637 | 5MM EndoscopeGCJ · Traditional | 06/14/1996SE |
Questions and answers
When was Endoscope cleared by the FDA?
Endoscope (K933106) received a 510(k) decision of Substantially Equivalent on October 19, 1993, 116 days after the submission was received.
What is the product code of K933106?
The FDA product code is ODF – Mini Endoscope, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.