# K970888: Iotec Trocar and Flexible Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Iotec Industries
- Decided: Jan 9, 1998 after 304 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 K931111 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940587: Flex-I-Port, Access Surgical Intl., Inc. (1994) Summary page 1.
- K931111: Endopath Disposable Flexible Surgical Cannula, Ethicon Endo-Surgery, Inc. (1993) Summary page 1.

## Indications for use
The product is intended to create a point of entry for curved endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure.

Source page: https://510kreport.com/device/K970888
Methodology: https://510kreport.com/methodology