# K170377: TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corporation
- Decided: Apr 5, 2017 after 57 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: 1 generation back to K003126 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003126: Bipolar Trigger-Flex Probe, Ellman Intl., Inc. (2001) Summary page 4.

## Most influential descendants
- K233425: FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) (2024), 0 descendants of its own

## Indications for use
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopically performed or supported surgeries. The types of surgery intended are: * Endoscopic procedures * Orthopedic coagulation * Neurosurgical coagulation The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.

Source page: https://510kreport.com/device/K170377
Methodology: https://510kreport.com/methodology