# K040602: Sureline Laparoscopic Clip Applier with Implantable Titanium Clips

- Pathway: 510(k) (Traditional)
- Applicant: Design Standards Corp.
- Decided: May 10, 2004 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
Longest line of descent: 3 generations back to K771021 (1977). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981645: Titanium Hemostatic Clip, Vitalitec Int'L., Inc. (1998) Summary page 1.
- K964109: Microsurge Laparoscopic Permaclip Cartridge with Implantable Clip, Microsurge, Inc. (1996) Summary page 1.
- K890941: Modified Suture Disp. Endoscopic Surgical Clip App, United States Surgical, A Division of Tyco Healthc (1989) Summary page 1.
- K851251: Auto/Manual Titanium Hemoclip Ligating Clip 527200, Edward Weck, Inc. (1985) Summary page 1.

## Cited in the summary but kept off the family tree
- K883081: Radkor, XG-515, Radkor, Inc. (1988). Our reading of the summary gave K883081, FDA’s number for Radkor, XG-515 (Radkor, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “United States Surgical Corporation”. Kept off the family tree. Summary page 1.
- K920387: Circlexo.3T X-Ray Tube Assembly, Shimadzu Medical Systems (1992). Our reading of the summary gave K920387, FDA’s number for Circlexo.3T X-Ray Tube Assembly (Shimadzu Medical Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Ethicon Endosurgery”. Kept off the family tree. Summary page 1.
- K905837: Pilling Weck. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Sureline Laparoscopic Clip Applier with Implantable Titanium clips is intended for use in a variety of laparoscopic procedures to occlude tubular structures and blood vessels. The tissue being ligated should be consistent with the size of the clip.

Source page: https://510kreport.com/device/K040602
Methodology: https://510kreport.com/methodology