# K971588: Evi Sutured-Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: Elective Vascular Intervention Inc. (Evi)
- Decided: Oct 24, 1997 after 176 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 9 cite it directly.
0 of 57 devices 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) Pilling Weck Hemoclip S15 Automatic Applier: named in the summary without a submission number
- (no number) U.S. Surgical ENDO CLIP Applier: named in the summary without a submission number
- (no number) Ethicon LIGACLIP Endoscopic Clip Applier: named in the summary without a submission number
- (no number) US Surgical VCS Clip and Clip Applier: named in the summary without a submission number
- (no number) Ethicon LIGACLIP Clip and Clip Applicr: named in the summary without a submission number

## Most influential descendants
- K994160: Coalescent Surgical Sutured-Clip (2000), 55 descendants of its own
- K012317: Coalescent Surgical U-Clip (2001), 52 descendants of its own
- K013664: Coalescent Surgical U-Clip (2002), 44 descendants of its own
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories (2002), 43 descendants of its own
- K023125: Coalescent U-Clip- and Accessories (2002), 42 descendants of its own

## Indications for use
The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip Applier™ are intended for endoscopic and non-endoscopic use in the creation of everting anastomoses in blood vessels, grafts and other tubular structures.

Source page: https://510kreport.com/device/K971588
Methodology: https://510kreport.com/methodology