Sterisheet Sterilization Wrap
FDA 510(k) K152291 · Andersen Sterilizers, Inc.
510(k) numberK152291
Submission
- Device name
- Sterisheet Sterilization Wrap
- Applicant
- Andersen Sterilizers, Inc.
Haw River, NC, US - Received
- August 13, 2015
- Decision date
- December 17, 2015
- 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 |
|---|---|---|
| K213296 | Anprolene SteriTest RRBIFRC · Traditional | 04/12/2022SE |
| K202879 | EOGas 4 Endo-SteriTest RRBIFRC · Traditional | 03/03/2021SE |
| K200336 | Tyvek Sterilization Pouches with Chevron SealFRG · Traditional | 11/12/2020SE |
| K200335 | Sterisheet Sterilization WrapFRG · Traditional | 11/12/2020SE |
| K200334 | AN1036 DosimeterJOJ · Traditional | 11/12/2020SE |
| K192980 | EOGas 4 Endo-SteriTestFRC · Traditional | 11/12/2020SE |
| K192978 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | 11/12/2020SE |
| K170439 | AN87 DosimeterJOJ · Traditional | 11/01/2017SE |
| K170437 | Sterisheet Sterilization WrapFRG · Traditional | 11/01/2017SE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | 10/31/2017SE |
Questions and answers
When was Sterisheet Sterilization Wrap cleared by the FDA?
Sterisheet Sterilization Wrap (K152291) received a 510(k) decision of Substantially Equivalent on December 17, 2015, 126 days after the submission was received.
What is the product code of K152291?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.