# K020574: Tissuelink Bipolar Floating Ball Device

- Pathway: 510(k) (Traditional)
- Applicant: Tissuelink Medical, Inc.
- Decided: May 20, 2002 after 88 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 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) TissueLink Monopolar Floating Ball: named in the summary without a submission number

## Most influential descendants
- K022532: Tissuelink Bipolar Floating Ball Device (2003), 25 descendants of its own
- K052859: Aquamantys Pump Generator System (2005), 24 descendants of its own
- K063639: Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 (2007), 7 descendants of its own
- K111732: Aquamantys SBS 5.0 Sheated Biopolar Sealer (2011), 5 descendants of its own
- K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar (2013), 4 descendants of its own

## Recalls of this device
- Jul 22, 2004 · Not classified · Z-1416-04: Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
- Jul 22, 2004 · Not classified · Z-1415-04: Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.

## Indications for use
The TissueLink Bipolar Floating Ball device is a sterile, single use bipolar electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic-sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, general and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K020574
Methodology: https://510kreport.com/methodology