Re-Bag Multi-Use Pouch, Large & Small
FDA 510(k) K954185 · Miltex, Inc.
510(k) numberK954185
Submission
- Device name
- Re-Bag Multi-Use Pouch, Large & Small
- Applicant
- Miltex, Inc.
Great Neck, NY, US - Received
- September 6, 1995
- Decision date
- December 4, 1995
- Decision
- Unknown (SESK)
- 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
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| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
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| 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 |
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More from Talladium España, SL
| 510(k) | Device | Decision |
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| K101653 | Miltex Thompson Cassettes; Miltex Surgical CassettesKCT · Traditional | 08/02/2010SE |
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| 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 |
| K050570 | Miltex Rigid Sterilization Container SystemKCT · Traditional | 07/25/2005SE |
| K043013 | Miltex Laparoscopic InstrumentsHET · Traditional | 03/04/2005SE |
| K013888 | Fixation (Steinmann) PinsHTY · Traditional | 05/01/2002SE |
| K823326 | Dental Instruments - Cutting InstrumentELA · Traditional | 11/24/1982SE |
Questions and answers
When was Re-Bag Multi-Use Pouch, Large & Small cleared by the FDA?
Re-Bag Multi-Use Pouch, Large & Small (K954185) received a 510(k) decision of Unknown on December 4, 1995, 89 days after the submission was received.
What is the product code of K954185?
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.