Instru-Safe Instrument Protection System
FDA 510(k) K142630 · Summit Medical, Inc.
510(k) numberK142630
Submission
- Device name
- Instru-Safe Instrument Protection System
- Applicant
- Summit Medical, Inc.
St. Paul, MN, US - Received
- September 17, 2014
- Decision date
- December 23, 2014
- 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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|---|---|---|---|
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| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
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| 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 |
|---|---|---|
| K180528 | InstruSafe(R) Sterilization ContainerKCT · Traditional | 11/16/2018SE |
| K173110 | GraftsiteBSP · Traditional | 05/18/2018SE |
| K170388 | ANCHORMAN Tibial Ligament Fixation DeviceMBI · Traditional | 07/25/2017SE |
| K162046 | MINNE TIES MMF Suture SystemDYX · Traditional | 04/11/2017SE |
| K151166 | Instru-Safe Instrument Protection SystemKCT · Traditional | 08/18/2015SE |
| K150540 | Instru-Safe Instrument Protection SystemKCT · Traditional | 06/22/2015SE |
| K142768 | Instru-Safe Instrument Protection SystemKCT · Traditional | 05/29/2015SE |
| K141513 | Instru-Safe Instrument Protection SystemKCT · Traditional | 12/15/2014SE |
| K140289 | Instru-Safe Instrument Protection SystemKCT · Traditional | 06/27/2014SE |
| K133015 | Instru-Safe Instrument Protection SystemKCT · Traditional | 03/13/2014SE |
Questions and answers
When was Instru-Safe Instrument Protection System cleared by the FDA?
Instru-Safe Instrument Protection System (K142630) received a 510(k) decision of Substantially Equivalent on December 23, 2014, 97 days after the submission was received.
What is the product code of K142630?
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.