Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping Insulated and Rat Tooth Forceps
FDA 510(k) K101298 · Endochoice, Inc.
510(k) numberK101298
Submission
- Device name
- Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping Insulated and Rat Tooth Forceps
- Applicant
- Endochoice, Inc.
Alpharetta, GA, US - Received
- May 10, 2010
- Decision date
- August 5, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
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| K103688 | G-Prox Ez Endoscopic GrasperOCZ · Special | Usgi Medical | 01/14/2011SE |
| K072684 | Mondeal Endoscopic Tissue Recession and Release SystemOCZ · Traditional | Mondeal North America, Inc. | 01/04/2008SE |
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| K152182 | Fuse Gastroscopy SystemFDS · Special | 12/10/2015SE |
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Questions and answers
When was Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping Insulated and Rat Tooth Forceps cleared by the FDA?
Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping Insulated and Rat Tooth Forceps (K101298) received a 510(k) decision of Substantially Equivalent on August 5, 2010, 87 days after the submission was received.
What is the product code of K101298?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.