Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Steriking Packaging for Medical Devices

K-Number: K221016 · 2022-05-05

ApplicantWipak OY
Decision Date2022-05-05
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steriking Packaging for Medical Devices is a medical device manufactured by Wipak OY. It received FDA 510(k) clearance on 2022-05-05 under approval number K221016. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steriking Packaging for Medical Devices?

Steriking Packaging for Medical Devices is a medical device that received FDA 510(k) clearance on 2022-05-05. It is manufactured by Wipak OY. The 510(k) number is K221016.

When was Steriking Packaging for Medical Devices approved by the FDA?

Steriking Packaging for Medical Devices received FDA 510(k) clearance on 2022-05-05, under approval number K221016.

What company makes Steriking Packaging for Medical Devices?

Steriking Packaging for Medical Devices is manufactured by Wipak OY.

What is the FDA product code for Steriking Packaging for Medical Devices?

The FDA product code for Steriking Packaging for Medical Devices is FRG.

Related Clinical Trials

NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT07232030 Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026) PMID: 42096274 Nanoparticle-based approaches to tackling urinary tract biofilms. Nanomedicine (London, England) (2026)

Other Devices by Wipak OY

K221377SteriKing LT-Blueline Pouches with Tyvek K210810Steiking Packaging for Medical Devices K231999Steriking® LT-Blueline Pouches with Tyvek® K231996Steriking® LT-Blueline Pouches with Tyvek® K221379Steriking LT-Blueline Pouches with Tyvek K232625Steriking® Pouch for Robotic Instruments

View all 7 devices →

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑