# K032132: Tissuelink Floating Ball Model 23-201-1

- Pathway: 510(k) (Special)
- Applicant: Tissuelink Medical, Inc.
- Decided: Aug 20, 2003 after 40 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.
44 later devices descend from it; 2 cite it directly.
0 of 45 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 Bipolar Floating Ball: named in the summary without a submission number

## Most influential descendants
- K052859: Aquamantys Pump Generator System (2005), 24 descendants of its own
- K050459: Atricure Isolator Transpolar Pen (2005), 18 descendants of its own
- K073605: Atricure Coolrail Linear Pen (2008), 13 descendants of its own
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 (2006), 13 descendants of its own
- K100501: Multifunctional Linear Pen (2010), 9 descendants of its own

## Indications for use
The TissueLink BPS bipolar sealer 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/K032132
Methodology: https://510kreport.com/methodology