# K971201: Auto Suture* Ilm** Kit

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jun 3, 1997 after 63 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.
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) AUTO SUTURE* Premium SURGICLIP*: named in the summary without a submission number
- (no number) Standard Hyperdermic Needle: named in the summary without a submission number
- (no number) Standard Syringe with LuerLock: named in the summary without a submission number
- (no number) Standard Sterile Marking Pen: named in the summary without a submission number
- (no number) Standard Surgical Ruler: named in the summary without a submission number

## Indications for use
The AUTO SUTURE* ILM** Procedure Kit is indicated for use in lymphatic mapping.

Source page: https://510kreport.com/device/K971201
Methodology: https://510kreport.com/methodology