# K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set

- Pathway: 510(k) (Traditional)
- Applicant: Louisville Laboratories, Inc.
- Decided: Mar 9, 1998 after 54 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 6 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K180701: SafePath Suturing System (2018), 1 descendant of its own
- K260197: Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (2026), 0 descendants of its own
- K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (2024), 0 descendants of its own
- K241111: AMT Suture Passer (2024), 0 descendants of its own
- K133414: Reprocessed Closure System (2014), 0 descendants of its own

## Recalls of this device
- Aug 29, 2023 · Class II · Z-0985-2024: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

## Indications for use
The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.

Source page: https://510kreport.com/device/K980123
Methodology: https://510kreport.com/methodology