# K014260: Tissuelink Solid Cylinder Monopolar Device

- Pathway: 510(k) (Traditional)
- Applicant: Tissuelink Medical, Inc.
- Decided: Mar 27, 2002 after 90 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 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
- K082568: Saline Enhanced Electrosurgical Resection (Seer) Device (2008), 4 descendants of its own
- K101057: Aquamantys Double Cone Bipolar Sealer Model: 23-310-1 (2011), 3 descendants of its own
- K121678: DTAD (2012), 2 descendants of its own
- K123429: Olympus Energy Power System (Eps) (2013), 1 descendant of its own
- K120537: AQUAMANTYS3 9.5 XL Bipolar Sealer (2012), 1 descendant of its own

## Recalls of this device
- Feb 7, 2005 · Not classified · Z-0563-05: The tip may separate from the device and render it unusable

## Indications for use
The TissueLink Solid Cylinder monopolar 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 blunt dissection, hemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K014260
Methodology: https://510kreport.com/methodology