# K232625: Steriking® Pouch for Robotic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Wipak OY
- Decided: Jun 7, 2024 after 283 days
- Product code: FRG (Wrap, Sterilization)
- 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: 3 generations back to K953776 (1995). 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)
- K221016: Steriking Packaging for Medical Devices, Wipak OY (2022) Summary page 6.

## Indications for use
Steriking® Pouch for Robotic Instruments serve as an enclosure for Intuitive Endowrist Robotic Instruments during steam sterilization that maintains the sterility of the enclosed medical devices until they are used. Pouches are intended for use as packaging material of Intuitive Endowrist Robotic Instruments for steam sterilization in health care establishments. The products are for single use only. The pouches allow sterilization, maintain sterility and enable aseptic presentation of packed medical device. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132°C for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 135°C for 3 minutes; Drying time of 16 minutes The maximum load for the Steriking® Pouch for Robotic Instruments is a single Intuitive Endowrist Robotic Instrument or other medical devices with a combined weight of metal and plastics of 2.6 pounds or less. Steriking® Pouch for Robotic Instruments consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic) with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. Steriking® Pouch for Robotic Instruments consists of pouch sizes that can be heat sealed, and pouch sizes that are self-sealed. For heat-sealed sizes: The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165°C-200°C (329°F - 392°F). Steriking® Pouch for Robotic Instruments have Dimensional heat-seal configurations (2 sizes 200mm x 800mm, 250mm x 900mm). Steriking® Pouch for Robotic Instruments with heat-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. For self-sealed sizes: The open end of the pouch is to be self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing of a pack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded along the pre-folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal. Steriking® Pouch for Robotic Instruments have Dimensional self-seal configurations (2 sizes 200mm x 800mm, 250mm x 875mm). Steriking® Pouch for Robotic Instruments with self-seal maintains the sterility of the enclosed devices for up to 1 year post Steam sterilization and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

Source page: https://510kreport.com/device/K232625
Methodology: https://510kreport.com/methodology