Sterile Pan Set
FDA 510(k) K842136 · Medi-Plast Intl., Inc.
510(k) numberK842136
Submission
- Device name
- Sterile Pan Set
- Applicant
- Medi-Plast Intl., Inc.
Walker, MI, US - Received
- May 30, 1984
- Decision date
- July 6, 1984
- 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 |
|---|---|---|
| K954284 | Medi-Plast 2 Port Manifold (Right on)DTL · Traditional | 02/12/1996SE |
| K873588 | 10CC Control SyringeFMF · Traditional | 10/23/1987SE |
| K863402 | Medi-Plast Disposable ManifoldDTL · Traditional | 10/22/1986SE |
| K861785 | Fluoroscope Band BagJAA · Traditional | 06/13/1986SE |
| K851489 | Arterial-Venous Compression Dressing · Traditional | 06/11/1985SE |
| K840021 | Operating Room Tray SetFSM · Traditional | 03/15/1984SE |
| K840022 | Heart Catheterization Tray SetDRE · Traditional | 02/04/1984SE |
| K811268 | Bottle-To-BottleKPE · Traditional | 06/18/1981SE |
| K811234 | I.V. Bottle (Ridgid)KPE · Traditional | 06/18/1981SE |
| K811233 | I.V. Plastic BagKPE · Traditional | 06/17/1981SE |
Questions and answers
When was Sterile Pan Set cleared by the FDA?
Sterile Pan Set (K842136) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 37 days after the submission was received.
What is the product code of K842136?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.