# K101080: Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX, Monopolar Forceps Model 09/XXX

- Pathway: 510(k) (Traditional)
- Applicant: Egon Faulhaber Surgical Instruments Pinzetten
- Decided: Jun 21, 2010 after 63 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bipolar and Monopolar Forceps from Guenter Bissinger Medizintechnik GmbH: named in the summary without a submission number
- (no number) Bipolar and Monopolar Forceps from Sutifer Medizintechnik GmbH: named in the summary without a submission number
- (no number) Bipolar and Monopolar Forceps from Kirwan Surgical Products (formerly New England Surgical Instrument Corp.): named in the summary without a submission number

## Most influential descendants
- K182773: Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps (2019), 2 descendants of its own
- K191847: Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps (2020), 1 descendant of its own
- K233351: Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable  (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable  (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable  (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable  (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable  (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force (2023), 0 descendants of its own
- K143662: Bissinger Monopolar Forceps and Cables (2015), 0 descendants of its own
- K131012: Sutter Bipolar Forceps - Supergliss (2013), 0 descendants of its own

## Indications for use
The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar and monopolar coagulation for general surgery where coagulation of soft tissue is needed. The Bipolar Forceps are used with the bipolar, and the Monopolar Forceps are used with the monopolar output for standard electrosurgical generators. The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended are: General surgery, Laryngeal coagulation, Orthopedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynecological coagulation (except for use in female sterilization), Urological coagulation, Ear-, Nose- and Throat coagulation.

Source page: https://510kreport.com/device/K101080
Methodology: https://510kreport.com/methodology