FRG — Wrap, Sterilization Class II
FDA product code FRG covers "Wrap, Sterilization", a Class II medical device regulated under 21 CFR 880.6850. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FRG
- Device Class
- Class II
- Regulation Number
- 880.6850
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261897 | o and m halyard | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HE | July 2, 2026 |
| K252823 | dukal | Dukal Crepe Paper Sterilization Wrap | May 28, 2026 |
| K253454 | o and m halyard | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; | May 18, 2026 |
| K251347 | sterivic medical co | Sterilization Pouch/Roll | January 28, 2026 |
| K251177 | guangdong maidi medical co | Self-Seal Sterilization Pouch and Roll | December 12, 2025 |
| K250306 | propper manufacturing co | Chex-All Sterilization Pouches and Tubes | October 31, 2025 |
| K243179 | yichang xinxin paper products co | Sterilization Pouch and Roll | June 26, 2025 |
| K250321 | george courey | GCI Sterilization Wrappers | June 6, 2025 |
| K243721 | wellmed dental medical supply co | Self Sealing Sterilization Pouches | April 25, 2025 |
| K250011 | turbett surgical | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 | April 4, 2025 |
| K241565 | anqing clean dental instrument technology co | Sterilization Package/Reel | February 24, 2025 |
| K242898 | shanghai jianzhong medical packaging co | Sterilization Pouches and Reels | February 21, 2025 |
| K243431 | medicom asia-pacific holdings ltd. taiwan branch | Medicom Sterilization Pouch and Reel | February 21, 2025 |
| K240438 | comercializadora brever | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (4 | November 4, 2024 |
| K242839 | shenzhen safesecure medical infection control tech co. | Safe Secure Sterilization Pouches and Rolls | October 16, 2024 |
| K242208 | primed medical products | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | October 7, 2024 |
| K241123 | km | Perpak Sterilization Tyvek Pouch | September 18, 2024 |
| K234132 | medline industries | Medline Reusable Sterilization Wrappers | September 17, 2024 |
| K234050 | o and m halyard | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, | September 16, 2024 |
| K240330 | o and m halyard | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilizati | August 7, 2024 |