# K980238: Gynex Extended Reach Needle

- Pathway: 510(k) (Traditional)
- Applicant: Gynex Corp.
- Decided: Aug 21, 1998 after 210 days
- Product code: HEE (Set, Anesthesia, Paracervical)
- Device class: 2
- Regulation: 21 CFR 884.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910252 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910252: Potocky Neddle (TM) Disposable Injection Needle, CooperSurgical, Inc. (1991) Summary page 1.

## Indications for use
1. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both. 2. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.

Source page: https://510kreport.com/device/K980238
Methodology: https://510kreport.com/methodology