Sterilization Wrap
FDA 510(k) K820521 · General Medical Co.
510(k) numberK820521
Submission
- Device name
- Sterilization Wrap
- Applicant
- General Medical Co.
Mchenry, IL, US - Received
- February 26, 1982
- Decision date
- March 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K926269 | Procedure KitLRO · Traditional | 08/27/1993SEKD |
| K912975 | Operand Lubricating JellyKMJ · Traditional | 09/27/1991SE |
| K912132 | Operand Lubricating JellyFHX · Traditional | 08/07/1991SE |
| K903669 | Genesis Insufflating CatheterBSY · Traditional | 09/12/1990SE |
| K900110 | Operand* Lubricating JellyKMJ · Traditional | 05/02/1990SE |
| K853635 | Subderm TMEGJ · Traditional | 12/20/1985SE |
| K844652 | C.A.S.E. ContainerFSM · Traditional | 12/12/1984SE |
| K831320 | DrionicEGJ · Traditional | 07/19/1983SE |
| K820689 | C.S.R. WrappersFRG · Traditional | 04/09/1982SE |
| K802231 | Air Viva IIBTM · Traditional | 10/10/1980SE |
Questions and answers
When was Sterilization Wrap cleared by the FDA?
Sterilization Wrap (K820521) received a 510(k) decision of Substantially Equivalent on March 18, 1982, 20 days after the submission was received.
What is the product code of K820521?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.