# K022532: Tissuelink Bipolar Floating Ball Device

- Pathway: 510(k) (Traditional)
- Applicant: Tissuelink Medical, Inc.
- Decided: Feb 12, 2003 after 196 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
Longest line of descent: 1 generation back to K020574 (2002). 1 ancestor in all.
25 later devices descend from it; 1 cites 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)
- K020574: Tissuelink Bipolar Floating Ball Device, Tissuelink Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K130110: Meddusa Bipolar System (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 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 and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K022532
Methodology: https://510kreport.com/methodology