# K980617: Modification to Reflex Aec Linear Stapler/Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Urohealth Systems, Inc.
- Decided: Apr 9, 1998 after 76 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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) Reflex AEC 35: named in the summary without a submission number
- (no number) Multifire GIA: named in the summary without a submission number
- (no number) Endo GIA 30: named in the summary without a submission number

## Indications for use
For use in a variety of open procedures, such as abdominal, pediatric, thoracic, gynecologic, etc. and for use in endoscopic and laparoscopic procedures to achieve hemostatic transection of vessels and other tissue structures.

Source page: https://510kreport.com/device/K980617
Methodology: https://510kreport.com/methodology