510(k) K770590
- Device
- SURGI-KIT
- Applicant
- ETHOX CORP.
- 510(k) number
- K770590
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-14
- Date received
- 1977-03-28
- 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
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8044099
- 3010363542
- 9610612
- 3018094310
- 3013114075
- 3013247477
- 3008868758
- 3038187466
- 8020776
- 1062741
- 8043792
- 3014553709
- 3015392401
- 3016555232
- 1057421
- 3011824442
- 3014409963
- 3008837339
- 3014421917
- 3009538923
- 3015612252
- 9680261
- 3012322232
- 3007389669
- 3005706667
- 3011373951
- 2184066
- 3010707607
- 9610773
- 3026606306
- 3036622014
- 9612074
- 3006742481
- 1418479
- 1314417
- 3011063460
- 3008864603
- 3013111692
- 3004203816
- 3009050824
- 1720499
- 3008114965
- 3003477135
- 3026593233
- 3009539885
- 3004976965
- 3043226252
- 3011137372
- 9611959
- 2134470
- 3008812560
- 3017820152
- 2936485
- 3010057495
- 3004153240
- 3011575197
- 3015181082
- 3015960676
- 1941138
- 3014635169
- 3022626486
- 9611367
- 3005409899
- 3017155536
- 1058020
- 3013665681
- 3010141593
- 9613348
- 1320894
- 2434839
- 1717344
- 3043164947
- 3008517893
- 2919128
- 3043543260
- 2518634
- 3005004799
- 3008261720
- 3001617766
- 3010684280
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262084 | S.I.N. Instruments Kits | S.I.N. Implant System Ltda | 2026-10-22 |
| K262042 | Sterilization Cassette (CASS-1) | Alliedstar Medical Equipment Co., Ltd. | 2026-10-14 |
| K253988 | LiteSet Trays | Nobel Biocare AB | 2026-09-08 |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026-09-04 |
| 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 |
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