SterilContainer S System
FDA 510(k) K182032 · Aesculap, Inc.
510(k) numberK182032
Submission
- Device name
- SterilContainer S System
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- July 30, 2018
- Decision date
- December 21, 2018
- 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
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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 |
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| K242762 | Aesculap Aicon® Series Container SystemKCT · Traditional | 05/13/2025SE |
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| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was SterilContainer S System cleared by the FDA?
SterilContainer S System (K182032) received a 510(k) decision of Substantially Equivalent on December 21, 2018, 144 days after the submission was received.
What is the product code of K182032?
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.