# K170381: Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy
- Decided: Sep 7, 2017 after 212 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
Longest line of descent: 7 generations back to K954171 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar, Medtronic Advanced Energy, LLC (2013) Summary page 4.

## Indications for use
The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and Aquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile, single-use bipolar electrosurgical devices intended to be used in conjunction with a qualified Pump Generator for delivery of Radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K170381
Methodology: https://510kreport.com/methodology