M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
FDA 510(k) K152743 · Microline Surgical, Inc.
510(k) numberK152743
Submission
- Device name
- M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
- Applicant
- Microline Surgical, Inc.
Beverly, MA, US - Received
- September 23, 2015
- Decision date
- February 8, 2016
- 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
Other 510(k)s with product code KCT
| 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 |
| 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 |
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| K213127 | ReNew Disposable Scissor TipsGEI · Traditional | 03/02/2022SE |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece…GEI · Traditional | 10/21/2020SE |
| K160706 | ReNew V Handpiece Laparoscopic InstrumentsGEI · Traditional | 10/19/2016SE |
| K152745 | ReNew Sterilization Trays(Catalog #3708 and #3709)KCT · Traditional | 05/12/2016SE |
| K124029 | Microline Flexible Ligating ShearsGEI · Traditional | 03/27/2013SE |
| K122086 | Thermal Ligating ShearsGEI · Traditional | 08/23/2012SE |
Questions and answers
When was M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) cleared by the FDA?
M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) (K152743) received a 510(k) decision of Substantially Equivalent on February 8, 2016, 138 days after the submission was received.
What is the product code of K152743?
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.