# K120898: Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar 8850XX Sealing CA

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Aug 3, 2012 after 130 days
- Product code: OTJ (Laparoscopic Single Port Access Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K940232 (1994). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110792: Gelpoint Path, Applied Medical Resources Corp. (2011) Summary page 3.
- K103253: Sils Port, Coviden (Formerly Registered AS US Surgical, A Div (2011) Summary page 1.
- K000180: Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal Endoscop, Richard Wolf Medical Instruments Corp. (2001) Summary page 1.
- K090275: Gelport Single Incision Access System, Applied Medical Resources Corp. (2009) Summary page 1.
- K110004: Asc Triport+ Laparoscopic Access Device, Advanced Surgical Concepts (2011) Summary page 1.

## Indications for use
The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).

Source page: https://510kreport.com/device/K120898
Methodology: https://510kreport.com/methodology