Powergrip Bipolar Coagulation Forceps, Model 824XXXXX
FDA 510(k) K033177 · Gunter Bissinger Medizintechnik GmbH
510(k) numberK033177
Submission
- Device name
- Powergrip Bipolar Coagulation Forceps, Model 824XXXXX
- Applicant
- Gunter Bissinger Medizintechnik GmbH
Amsterdam, Nh, NL - Received
- October 1, 2003
- Decision date
- March 11, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172368 | Bipolar Micro-Coagulation ForcepsGEI · Traditional | 04/05/2018SE |
Questions and answers
When was Powergrip Bipolar Coagulation Forceps, Model 824XXXXX cleared by the FDA?
Powergrip Bipolar Coagulation Forceps, Model 824XXXXX (K033177) received a 510(k) decision of Substantially Equivalent on March 11, 2004, 162 days after the submission was received.
What is the product code of K033177?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.