# K974137: Uromed Needle Grasper

- Pathway: 510(k) (Traditional)
- Applicant: Uromed Corp.
- Decided: Jan 30, 1998 after 88 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Cook Endoscopic Grasping Forceps: named in the summary without a submission number
- (no number) Laurus Medical Suture Placement System: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K924196: Laparoscopic Needle Holder, Nusurg, Inc. (1993). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K974137
Methodology: https://510kreport.com/methodology