Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization
FDA 510(k) K122507 · Cardinal Health200, LLC
510(k) numberK122507
Submission
- Device name
- Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization
- Applicant
- Cardinal Health200, LLC
Waukegan, IL, US - Received
- August 17, 2012
- Decision date
- September 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FRG – Wrap, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code FRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional | O&M Halyard, Inc. | 07/02/2026SE |
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | Dukal, LLC | 05/28/2026SE |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 05/18/2026SE |
| K251347 | Sterilization Pouch/RollFRG · Traditional | Sterivic Medical Co., Ltd. | 01/28/2026SE |
| K251177 | Self-Seal Sterilization Pouch and RollFRG · Traditional | Guangdong Maidi Medical Co., Ltd. | 12/12/2025SE |
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | Propper Manufacturing Co., Inc. | 10/31/2025SE |
| K243179 | Sterilization Pouch and RollFRG · Traditional | Yichang Xinxin Paper Products Co., Ltd. | 06/26/2025SE |
| K250321 | GCI Sterilization WrappersFRG · Traditional | George Courey, Inc. | 06/06/2025SE |
| K243721 | Self Sealing Sterilization PouchesFRG · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 04/25/2025SE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional | Turbett Surgical | 04/04/2025SE |
More from Turbett Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K241780 | Cardinal Health Nitrile Exam GlovesLZA · Special | 08/23/2024SE |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument PocketsFYA · Traditional | 07/27/2023SE |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | 06/21/2023SE |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express…JOW · Traditional | 04/03/2023SE |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveKGO · Traditional | 09/26/2021SE |
| K211390 | Nitrile Blue Powder-free Examination GloveLZA · Traditional | 08/28/2021SE |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR…FYA · Traditional | 07/29/2020SE |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…FYA · Traditional | 03/20/2020SE |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam StripFXX · Traditional | 12/02/2019SE |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC · Traditional | 04/26/2019SE |
Questions and answers
When was Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization cleared by the FDA?
Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization (K122507) received a 510(k) decision of Substantially Equivalent on September 26, 2012, 40 days after the submission was received.
What is the product code of K122507?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.