510(k) K033177
K033177 is an FDA 510(k) premarket notification submitted by Gunter Bissinger Medizintechnik GmbH for the device "POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX". The FDA issued a decision of Substantially Equivalent on Mar 11, 2004. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Gunter Bissinger Medizintechnik GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 2004
- Date Received
- Oct 1, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type
- 510(k)