# K152743: M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

- Pathway: 510(k) (Traditional)
- Applicant: Microline Surgical, Inc.
- Decided: Feb 8, 2016 after 138 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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 K844002 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980065: C/T Med-Systems Cassette System, C/T Med System, Ltd. (1998) Summary page 4.

## Indications for use
Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization tray (Catalog# 3706) is maintained until used. The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, 4.94" height, and 0.90"width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses. The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of 132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.

Source page: https://510kreport.com/device/K152743
Methodology: https://510kreport.com/methodology