# K223689: Disposable Needle Guides and Grids

- Pathway: 510(k) (Traditional)
- Applicant: Advance Medical Designs, Inc.
- Decided: Aug 2, 2023 after 236 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: 2 generations back to K875128 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970514: Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide, CIVCO Medical Instruments Co., Inc. (1997). Our reading of the summary gave K972514, FDA’s number for Laserex LP1532 Photocoagulator (Ellex Medical Pty, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Disposable Endocavity Needle / Biopsy Guide”. Summary page 7.

## Most influential descendants
- K260161: SmartGuide Disposable Guides and Grids (2026), 0 descendants of its own

## Indications for use
"Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention by providing fixed guiding for the precise insertion of linear instruments, such as needles. The Needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam."

Source page: https://510kreport.com/device/K223689
Methodology: https://510kreport.com/methodology