Basics Endoscopy System
FDA 510(k) K941464 · Cox Medical Ent., Inc.
510(k) numberK941464
Submission
- Device name
- Basics Endoscopy System
- Applicant
- Cox Medical Ent., Inc.
Ventura, CA, US - Received
- March 28, 1994
- Decision date
- August 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
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|---|---|---|---|
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| K191900 | Single Use Grasping ForcepsOCZ · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/27/2020SE |
| K152802 | Grasping ForcepsOCZ · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 01/21/2016SE |
| K150939 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 06/08/2015SE |
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| K133736 | Endoscopic Suture CutterOCZ · Traditional | United States Endoscopy Group, Inc. | 01/07/2014SE |
| K120084 | Endoscopic Retrieval DeviceOCZ · Traditional | United States Endoscopy Group, Inc. | 05/30/2012SE |
| K103688 | G-Prox Ez Endoscopic GrasperOCZ · Special | Usgi Medical | 01/14/2011SE |
| K101298 | Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping…OCZ · Traditional | Endochoice, Inc. | 08/05/2010SE |
More from Endochoice, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950689 | UcbMNL · Traditional | 03/06/1995SE |
| K946360 | Modular Biopsy ForcepFCL · Traditional | 03/06/1995SE |
| K940911 | Basics Endoscopy SystemKGE · Traditional | 05/16/1994SE |
| K932790 | Thermal OptionKGE · Traditional | 01/28/1994SE |
| K935250 | Accu-PathFCL · Traditional | 01/21/1994SE |
| K924655 | Cox Disposable Endoscope Cleaning BRUSH(CB-X2)FEB · Traditional | 12/15/1992SE |
| K923671 | Cox Disposable Polypectomy SnaresFDI · Traditional | 10/13/1992SE |
| K923672 | Cox Disposable Endoscope Cleaning BrushFEB · Traditional | 09/23/1992SE |
| K923489 | Cox Disposable Retrieval DevicesOCZ · Traditional | 09/23/1992SE |
| K914466 | Cox Disposable Cytology BrushesFDX · Traditional | 10/25/1991SE |
Questions and answers
When was Basics Endoscopy System cleared by the FDA?
Basics Endoscopy System (K941464) received a 510(k) decision of Substantially Equivalent on August 5, 1994, 130 days after the submission was received.
What is the product code of K941464?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.