PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
FDA 510(k) K253791 · DePuy Mitek, Inc.
510(k) numberK253791
Submission
- Device name
- PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
- Applicant
- DePuy Mitek, Inc.
Raynham, MA, US - Received
- November 28, 2025
- Decision date
- February 26, 2026
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K243589 | PAL Sterilization CaseKCT · Traditional | Microaire Surgical Instruments, LLC | 06/20/2025SE |
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| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMAI · Special | 03/15/2024SE |
| K233675 | FMS VUE Fluid Management and Tissue Debridement SystemHRX · Traditional | 02/26/2024SE |
| K143475 | VAPR Tripolar Suction ElectrodeGEI · Traditional | 04/03/2015SE |
| K120449 | Healix Advance PEEK AnchorHWC · Traditional | 05/11/2012SE |
| K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…NEW · Special | 04/23/2008SE |
| K060664 | Fastin RC AnchorHWC · Traditional | 06/06/2006SE |
| K043298 | Blue Orthocord SutureNEW · Special | 12/10/2004SE |
| K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor…JDR · Special | 05/28/2004SE |
Questions and answers
When was PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid cleared by the FDA?
PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid (K253791) received a 510(k) decision of Substantially Equivalent on February 26, 2026, 90 days after the submission was received.
What is the product code of K253791?
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.