XBO1-824-18/19/20 Biopsy Forceps
FDA 510(k) K012074 · The Olympus Optical Co.
510(k) numberK012074
Submission
- Device name
- XBO1-824-18/19/20 Biopsy Forceps
- Applicant
- The Olympus Optical Co.
Melville, NY, US - Received
- July 2, 2001
- Decision date
- September 25, 2001
- 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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|---|---|---|---|
| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | Karl Storz SE & CO. KG | 06/03/2026SE |
| K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…OCZ · Traditional | Envision Endoscopy | 12/20/2024SE |
| 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 |
| K141058 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 08/01/2014SE |
| 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 |
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| K031305 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 09/23/2003SE |
| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VEOB · Traditional | 07/24/2003SE |
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | 07/16/2003SE |
| K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8ODG · Traditional | 05/09/2003SE |
| K030194 | XUES-41 Endoscopic Electrosurgical UnitKNS · Traditional | 03/24/2003SE |
| K024138 | Heat Scissors Generator Set and Heat Scissors HandpieceGEI · Traditional | 03/12/2003SE |
| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 02/12/2003SE |
| K021852 | Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesGEI · Traditional | 02/11/2003SE |
Questions and answers
When was XBO1-824-18/19/20 Biopsy Forceps cleared by the FDA?
XBO1-824-18/19/20 Biopsy Forceps (K012074) received a 510(k) decision of Substantially Equivalent on September 25, 2001, 85 days after the submission was received.
What is the product code of K012074?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.