Miltex Rigid Sterilization Container System
FDA 510(k) K050570 · Miltex, Inc.
510(k) numberK050570
Submission
- Device name
- Miltex Rigid Sterilization Container System
- Applicant
- Miltex, Inc.
York, PA, US - Received
- March 4, 2005
- Decision date
- July 25, 2005
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K101653 | Miltex Thompson Cassettes; Miltex Surgical CassettesKCT · Traditional | 08/02/2010SE |
| K092855 | Miltex Membrane Tack KitDZL · Traditional | 12/29/2009SE |
| K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…EJI · Traditional | 03/09/2009SE |
| K072563 | Miltex Rigid Container SystemsKCT · Traditional | 02/12/2008SE |
| K061033 | Miltex Rigid Sterilization Container System, (47 Components)KCT · Traditional | 12/12/2006SE |
| K052018 | Miltex Ligating ClipFZP · Traditional | 11/04/2005SE |
| K043013 | Miltex Laparoscopic InstrumentsHET · Traditional | 03/04/2005SE |
| K013888 | Fixation (Steinmann) PinsHTY · Traditional | 05/01/2002SE |
| K954185 | Re-Bag Multi-Use Pouch, Large & SmallKCT · Traditional | 12/04/1995SESK |
| K823326 | Dental Instruments - Cutting InstrumentELA · Traditional | 11/24/1982SE |
Questions and answers
When was Miltex Rigid Sterilization Container System cleared by the FDA?
Miltex Rigid Sterilization Container System (K050570) received a 510(k) decision of Substantially Equivalent on July 25, 2005, 143 days after the submission was received.
What is the product code of K050570?
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.