# K101671: Single Site Flexible Bladeless Obturator

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Jun 25, 2010 after 11 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: 1 generation back to K010007 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010007: Adapt Laparoscopic Port & Adapt Reducer Cap, Taut, Inc. (2001) Summary page 2.

## Indications for use
The Single-Site TM Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

Source page: https://510kreport.com/device/K101671
Methodology: https://510kreport.com/methodology