# K131012: Sutter Bipolar Forceps - Supergliss

- Pathway: 510(k) (Traditional)
- Applicant: Sutter Medizintechnik GmbH
- Decided: Aug 23, 2013 after 134 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K923332 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101080: Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX, Monopolar Forceps Model 09/XXX, Egon Faulhaber Surgical Instruments Pinzetten (2010)
- K051429: Claris Non-Stick Bipolar Forceps, Guenter Bissinger Medizintechnik GmbH (2005) Summary page 1.

## Indications for use
Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation. Indications: General surgery, Orthopaedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynaecological coagulation (except for use in female sterilisation), Urological coagulation, Ear-, Nose- and Throat coagulation. Contraindications: Sutter Bipolar Forceps SuperGliss have not been shown to be effective for tubal sterilisation or tubal coagulation for sterilisation procedures and should not be used for this purpose.

Source page: https://510kreport.com/device/K131012
Methodology: https://510kreport.com/methodology