Biopsy Scissors
FDA 510(k) K942030 · Surgical Technologies, Inc.
510(k) numberK942030
Submission
- Device name
- Biopsy Scissors
- Applicant
- Surgical Technologies, Inc.
Miami Lakes, FL, US - Received
- April 26, 1994
- Decision date
- June 27, 1994
- 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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|---|---|---|---|
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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 |
| 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 |
|---|---|---|
| K941992 | CystoscopeFBO · Traditional | 11/30/1995SE |
| K942029 | ArthroscopeHRX · Traditional | 11/08/1995SE |
| K946136 | Infinitech Lighted Infusion CannulaMPA · Traditional | 10/02/1995SE |
| K952566 | OscilflatorMAV · Traditional | 08/31/1995SE |
| K951918 | Surgical Technologies, Inc. SyringeFMF · Traditional | 07/20/1995SE |
| K950683 | Arthrogram TrayJAA · Traditional | 05/06/1995SE |
| K946135 | Infinitech Aspirating Laser ProbeHQE · Traditional | 04/18/1995SE |
| K946181 | Infinitech Soft Tip Flute NeedleHQE · Traditional | 03/14/1995SE |
| K942482 | Pressure Monitoring ExtensionDQO · Traditional | 06/14/1994SE |
| K941161 | Flexible Grasping ForcepsEOQ · Traditional | 05/04/1994SE |
Questions and answers
When was Biopsy Scissors cleared by the FDA?
Biopsy Scissors (K942030) received a 510(k) decision of Substantially Equivalent on June 27, 1994, 62 days after the submission was received.
What is the product code of K942030?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.