# K193587: Sutter Swyng non-stick bipolar forceps, single-use

- Pathway: 510(k) (Traditional)
- Applicant: Sutter Medizintechnik GmbH
- Decided: Feb 10, 2020 after 49 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K884656 (1988). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162469: CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps, Medos International SARL (2016) Summary page 4.

## Most influential descendants
- K233346: Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable  (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable  (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable  (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable  (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable  (HMAL20/010); (2023), 0 descendants of its own

## Recalls of this device
- Jun 23, 2020 · Class II · Z-2744-2020: The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol 

## Indications for use
Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue.

Source page: https://510kreport.com/device/K193587
Methodology: https://510kreport.com/methodology