Sterrad Sterilization Pouch
FDA 510(k) K951295 · Advanced Sterilization Products
510(k) numberK951295
Submission
- Device name
- Sterrad Sterilization Pouch
- Applicant
- Advanced Sterilization Products
Irvin, CA, US - Received
- March 22, 1995
- Decision date
- May 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| 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 |
|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104)MLR · Traditional | 04/15/2026SE |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104)MLR · Traditional | 04/14/2025SE |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…JOJ · Traditional | 07/05/2024SE |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104)…MLR · Traditional | 07/05/2024SE |
| K220404 | STERRAD NX with ALLClear TechnologyMLR · Traditional | 05/16/2022SE |
| K212174 | STERRAD 100NX Sterilizer with ALLClear TechnologyMLR · Traditional | 10/09/2021SE |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…KCT · Traditional | 07/31/2017SE |
| K162007 | STERRAD NX SterilizerMLR · Special | 02/16/2017SE |
| K160818 | STERRAD® NX Sterilizer with ALLClear TechnologyMLR · Traditional | 09/27/2016SE |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR · Traditional | 09/26/2016SE |
Questions and answers
When was Sterrad Sterilization Pouch cleared by the FDA?
Sterrad Sterilization Pouch (K951295) received a 510(k) decision of Substantially Equivalent on May 19, 1995, 58 days after the submission was received.
What is the product code of K951295?
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.