SteriTite Containers System & MediTray Products
FDA 510(k) K161415 · Case Medical, Inc.
510(k) numberK161415
Submission
- Device name
- SteriTite Containers System & MediTray Products
- Applicant
- Case Medical, Inc.
South Hackensack, NJ, US - Received
- May 23, 2016
- Decision date
- February 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | 06/03/2026SE |
| K240898 | SteriTite rigid reusable sterilization container with MediTray ProductsKCT · Traditional | 07/31/2024SE |
| K221492 | SteriTite Container System with MediTray PartsKCT · Traditional | 10/07/2022SE |
| K212711 | SteriTite Container System with MediTray ProductsKCT · Traditional | 04/29/2022SE |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray…KCT · Traditional | 06/13/2018SE |
| K112904 | Steritec Containers System & Meditray ProductsFRG · Traditional | 01/24/2012SE |
| K110682 | Steritite Container System & Meditray ProductsKCT · Traditional | 07/01/2011SE |
| K090068 | Steritite Universal Container System and Meditray ProductsFRG · Traditional | 02/24/2010SE |
| K080558 | Steritite Container System & Meditray ProductsFRG · Traditional | 12/05/2008SE |
| K022978 | Steritite Container with Flashtite Valve Plate(S) & Meditray ProductsFRG · Traditional | 05/09/2003SE |
Questions and answers
When was SteriTite Containers System & MediTray Products cleared by the FDA?
SteriTite Containers System & MediTray Products (K161415) received a 510(k) decision of Substantially Equivalent on February 10, 2017, 263 days after the submission was received.
What is the product code of K161415?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.