# K062821: U-Clip Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Dec 19, 2006 after 90 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: 10 generations back to K933887 (1993). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062057: U-Clip Device, Model NC65, Medtronic Vascular (2006) Summary page 1.
- K053252: U-Clip Device, Models B140, B160 and B180, Medtronic Vascular (2005) Summary page 1.
- K013664: Coalescent Surgical U-Clip, Coalescent Surgical (2002) Summary page 1.
- K001625: Pronova Nonabsorbable Suture, Usp, ETHICON, Inc. (2000) Summary page 1.
- K981582: Surgilon, Dermalon, & Ophthalon, Davis & Geck, Inc. (1998) Summary page 1.

## Indications for use
The U-CLIPTM Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.

Source page: https://510kreport.com/device/K062821
Methodology: https://510kreport.com/methodology