Bissinger Detachable Bipolar Coagulation-Forceps
FDA 510(k) K970968 · Guenter Bissinger Medizintechnik GmbH
510(k) numberK970968
Submission
- Device name
- Bissinger Detachable Bipolar Coagulation-Forceps
- Applicant
- Guenter Bissinger Medizintechnik GmbH
Teningen, DE - Received
- March 17, 1997
- Decision date
- May 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K213042 | Supra Non-Stick Bipolar ForcepsGEI · Abbreviated | 11/17/2022SE |
| K150024 | Bissinger Monopolar CablesGEI · Traditional | 02/20/2015SE |
| K051429 | Claris Non-Stick Bipolar ForcepsGEI · Traditional | 07/29/2005SE |
| K042077 | Bitech Bipolar ScissorsGEI · Traditional | 10/27/2004SE |
| K981919 | Bissinger Cables, Cat. No. 801000XXGEI · Traditional | 08/06/1998SE |
Questions and answers
When was Bissinger Detachable Bipolar Coagulation-Forceps cleared by the FDA?
Bissinger Detachable Bipolar Coagulation-Forceps (K970968) received a 510(k) decision of Substantially Equivalent on May 21, 1998, 430 days after the submission was received.
What is the product code of K970968?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.