510(k) K241927
- Device
- Synthes Graphic Case & Tray System
- Applicant
- Synthes GmbH
- 510(k) number
- K241927
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-28
- Date received
- 2024-07-01
- Regulation
- 880.6850
- Classification name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas Shea
- Address
- Luzernstrasse 21 Zuchwil CH 4528 4528
FDA Registration Numbers#
- 1834331
- 3008309062
- 3005360851
- 1221053
- 1526534
- 3026612481
- 2027754
- 1226230
- 3016438694
- 3006008984
- 3013868968
- 3009719225
- 3042940623
- 3018094310
- 3008534770
- 3011276344
- 1828464
- 3003120897
- 3027345187
- 2020394
- 3013283620
- 3017619652
- 3003935342
- 3003477135
- 3004112448
- 8010099
- 1222780
- 3011063460
- 9680845
- 2024312
- 3013357025
- 3011577940
- 3005694091
- 3015746537
- 1056276
- 3003790304
- 9611367
- 8010177
- 3003394627
- 3004193466
- 3007487007
- 3003236702
- 3014579188
- 2183301
- 3015895045
- 3023155873
- 3006948427
- 3012236936
- 3014663814
- 1833920
- 2020601
- 3013247477
- 3038718579
- 1835251
- 3020767943
- 3005497913
- 3010041430
- 3005741909
- 9611992
- 3015224777
- 3010684280
- 3005900820
- 3008693672
- 3014553709
- 1017294
- 1923569
- 3006639944
- 3009417901
- 9611959
- 2424366
- 3015895145
- 3008770252
- 3008135745
- 9610773
- 8043971
- 3006554912
- 9610612
- 3008864603
- 3009540749
- 1056350
Source Documents#
Other 510(k) Records For Product Code KCT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 |
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | DePuy Mitek, Inc. | 2026-02-26 |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025-06-20 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025-05-01 |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) | Prismatik Dentalcraft, Inc. | 2025-03-21 |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | 2025-02-19 |
| K243317 | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025-02-11 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 |