# K014248: DND 202 Manual Urological Digital Needle Driver

- Pathway: 510(k) (Traditional)
- Applicant: Urogyn, Ltd.
- Decided: Mar 21, 2002 after 85 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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) DND 101™ device: named in the summary without a submission number
- (no number) Deschamps™ device: named in the summary without a submission number

## Indications for use
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of vaginal prolapse.

Source page: https://510kreport.com/device/K014248
Methodology: https://510kreport.com/methodology