PAL Sterilization Case
FDA 510(k) K243589 · Microaire Surgical Instruments, LLC
510(k) numberK243589
Submission
- Device name
- PAL Sterilization Case
- Applicant
- Microaire Surgical Instruments, LLC
Charlottesville, VA, US - Received
- November 20, 2024
- Decision date
- June 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code KCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
More from Talladium España, SL
| 510(k) | Device | Decision |
|---|---|---|
| K244026 | PAL 7020 ConsoleQPB · Traditional | 04/25/2025SE |
| K242804 | PAL Aspiration SystemQPB · Traditional | 12/30/2024SE |
| K223406 | SmartRelease Endoscopic Soft Tissue Release SystemHRX · Traditional | 02/02/2023SE |
| K220318 | PAL Infiltration SystemQPB · Traditional | 10/14/2022SE |
| K212024 | PAL SystemQPB · Traditional | 06/10/2022SE |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release SystemHRX · Traditional | 06/24/2021SE |
| K192694 | PAL Single-Use CannulasQPB · Traditional | 05/14/2020SE |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release SystemHRX · Traditional | 11/06/2018SE |
| K171286 | PAL Multi-Use Cannulas and PAL Manual WandQPB · Traditional | 10/13/2017SE |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic PackMUU · Traditional | 05/22/2015SE |
Questions and answers
When was PAL Sterilization Case cleared by the FDA?
PAL Sterilization Case (K243589) received a 510(k) decision of Substantially Equivalent on June 20, 2025, 212 days after the submission was received.
What is the product code of K243589?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.