Submission Details
| 510(k) Number | K161910 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 2016 |
| Decision Date | April 20, 2017 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cardinal Health Sterilization Wrap
Apr 2017
Decision
282d
Days
Class 2
Risk
About This 510(k) Submission
K161910 is an FDA 510(k) clearance for the Cardinal Health Sterilization Wrap, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on April 20, 2017, 282 days after receiving the submission on July 12, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.
Device Classification
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6850 |
Manufacturer
Similar Devices — FRG Wrap, Sterilization
All 319
K251347 · Sterivic Medical Co., Ltd.
· Jan 2026
K251177 · Guangdong Maidi Medical Co., Ltd.
· Dec 2025
K250306 · Propper Manufacturing Co., Inc.
· Oct 2025
K243179 · Yichang Xinxin Paper Products Co., Ltd.
· Jun 2025
K250321 · George Courey, Inc.
· Jun 2025
K243721 · Wellmed Dental Medical Supply Co., Ltd.
· Apr 2025
More from Cardinal Health200, LLC
View all
K241780
· LZA · Aug 2024
K230838
· FYA · Jul 2023
K223376
· MEG · Jun 2023
K230028
· JOW · Apr 2023
K201592
· KGO · Sep 2021