K193561 is an FDA 510(k) clearance for the Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Weihai Xingtai Packaging Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on April 15, 2020, 114 days after receiving the submission on December 23, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K193561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | April 15, 2020 |
| Days to Decision | 114 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |