# K971115: GE Medical-Needle Guide for SV, TR Andatf, Acuson-Needle Guide

- Pathway: 510(k) (Traditional)
- Applicant: Protek Medical Products, Inc.
- Decided: Jun 13, 1997 after 78 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K875128 (1988). 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)
- K875128: Trans/R Needle Guide, CIVCO Medical Instruments Co., Inc. (1988) Summary page 2.
- (no number) Amedic needle guide: named in the summary without a submission number
- (no number) GE Medical needle guide: named in the summary without a submission number

## Indications for use
Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.

Source page: https://510kreport.com/device/K971115
Methodology: https://510kreport.com/methodology