# K241111: AMT Suture Passer

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Jul 5, 2024 after 74 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930738 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set, Louisville Laboratories, Inc. (1998) Summary page 4.
- K193612: AMT Suture Delivery System, Applied Medical Technology, Inc. (2020) Summary page 4.
- K192490: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch, Teleflex Medical (2020) Summary page 4.
- K182832: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set, Cook Incorporated (2019) Summary page 4.

## Indications for use
The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

Source page: https://510kreport.com/device/K241111
Methodology: https://510kreport.com/methodology