# K990854: Innerdyne Radially Expanding Dilation, Red Device

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: Aug 2, 1999 after 140 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) InnerDyne, Inc., R.E.D.® device: named in the summary without a submission number
- (no number) InnerDyne, Inc., Step® device: named in the summary without a submission number

## Indications for use
The InnerDyne, Inc., RED® device is intended for use during minimally invasive surgery to provide temporary dilation access to the abdominal/peritoneal cavity and to the lumen of specified internal organs to establish a port of entry for diagnostic, therapeutic, and operative instruments. Typical procedures for product use include: Laparoscopic access to the abdominal/peritoneal cavity; Percutaneous gastrostomy; Percutaneous enterostomy; Percutaneous cystostomy; Percutaneous cholescystostomy; and Dilation of biliary and urethral strictures.

Source page: https://510kreport.com/device/K990854
Methodology: https://510kreport.com/methodology