# K925015: Sterile Suture Removal Kit

- Pathway: 510(k) (Traditional)
- Applicant: Customed, Inc.
- Decided: Jun 7, 1993 after 256 days
- Product code: MCZ (Suture Removal Kit)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 7, 2016 · Class II · Z-1398-2016: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Jul 10, 2015 · Class II · Z-2549-2015: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Source page: https://510kreport.com/device/K925015
Methodology: https://510kreport.com/methodology