# K990493: Innerdyne Generic Radially Expanding Dilation, G-Red Device

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: May 18, 1999 after 90 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
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., Stap® device versions: named in the summary without a submission number
- (no number) InnerDyne, Inc., R.E.D.® device versions: named in the summary without a submission number

## Indications for use
The InnerDyne, Inc., G-RED™ device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures. . Percutaneous urological access, for typical procedures such as: . Percutaneous nephroscopy . Percutaneous bladder access (suprapubic) . Percutaneous laparoscopic access to primary body cavities (i.e., abdominal and thoracic), both primary and secondary punctures; and ] Percutaneous access into hollow body organs.

Source page: https://510kreport.com/device/K990493
Methodology: https://510kreport.com/methodology