# K103253: Sils Port

- Pathway: 510(k) (Traditional)
- Applicant: Coviden (Formerly Registered AS US Surgical, A Div
- Decided: Feb 24, 2011 after 113 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 6 generations back to K940232 (1994). 26 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K093372: Sils Port Model SILSPT15, Covidien Lp, Formerly Registered AS Tyco Healthcar (2009) Summary page 1.

## Most influential descendants
- K110792: Gelpoint Path (2011), 3 descendants of its own
- K133393: Gelpoint Path Transanal Access Platform (2014), 1 descendant of its own
- K171701: GelPOINT Path Transanal Access Platform (2017), 0 descendants of its own
- K120898: Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar 8850XX Sealing CA (2012), 0 descendants of its own

## Indications for use
The SILS™ Port device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.

Source page: https://510kreport.com/device/K103253
Methodology: https://510kreport.com/methodology