510(k) K182414
- Device
- Aesculap® SterilContainer(TM) S2 System
- Applicant
- Aesculap, Inc.
- 510(k) number
- K182414
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-05
- Date received
- 2018-09-04
- 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
- Sierra Mertz
- Address
- 3773 Corporate Pkwy. Center Valley PA US 18034 18034
FDA Registration Numbers#
- 3004203816
- 1833920
- 9680845
- 3006639944
- 3014615028
- 2132732
- 9710524
- 3013247477
- 1030489
- 1222780
- 3002808270
- 3014334038
- 2435946
- 3043164947
- 3011373951
- 9680735
- 1056276
- 3008864603
- 3027345187
- 3007389669
- 3005741909
- 9613277
- 3009417901
- 9680261
- 3003418325
- 3015960676
- 3005409899
- 3008868758
- 1314417
- 3003935342
- 1017294
- 1226230
- 3017155536
- 2134470
- 2431166
- 2424366
- 3005694091
- 3017949824
- 8044099
- 2023811
- 3014342096
- 3009968482
- 1319130
- 3007695749
- 1221053
- 2183301
- 3000270450
- 3010687973
- 3015895045
- 2919128
- 3008114965
- 2249529
- 2087234
- 3008132392
- 8030674
- 3008135745
- 1828288
- 1450428
- 3012236936
- 3003230618
- 3011533888
- 3009540749
- 1723170
- 2020394
- 1835251
- 3013114075
- 3004112448
- 3013283620
- 9681851
- 9616096
- 3014553709
- 1223422
- 1423662
- 3010707607
- 3020584246
- 1043653
- 1056553
- 3043543260
- 8043971
- 9614404
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 |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025-03-28 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases