510(k) K854063
- Device
- MICROVASIVE SILICONE SPRAY
- Applicant
- MICROVASIVE
- 510(k) number
- K854063
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-10-25
- Date received
- 1985-10-04
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAMUEL D WADE
- Address
- 31 Maple St. Milford MA US 01757 01757
FDA Registration Numbers#
- 3014334038
- 3015895045
- 3013357025
- 3043237009
- 3011577940
- 3005497913
- 3010157088
- 1221053
- 3014967149
- 3010141593
- 3014290448
- 3011575197
- 1828288
- 1935627
- 3009110133
- 3004464325
- 3006783837
- 3004215117
- 3012421607
- 3000270450
- 8030674
- 3009538923
- 3004153240
- 3017155536
- 1421879
- 3004201263
- 1450428
- 3043226252
- 1418005
- 3009539885
- 3013557562
- 3012627460
- 9611992
- 2024312
- 3005900820
- 3002259632
- 2518634
- 2248608
- 3013546462
- 2249529
- 3010772758
- 1058020
- 2027754
- 3011276344
- 3012055599
- 8010099
- 3009968482
- 3003418325
- 1926681
- 1221934
- 3004491689
- 3008135745
- 3015960676
- 3009719225
- 1314417
- 1941138
- 2424366
- 3009307953
- 1421101
- 3004080920
- 9611367
- 2084725
- 1423662
- 3003790304
- 3007367732
- 3020331900
- 3005071827
- 3015746537
- 3038549074
- 3042940623
- 3027345187
- 9610612
- 3009050824
- 1717344
- 3015181082
- 9617542
- 1043653
- 3003236702
- 3013665681
- 3014579188
Source Documents#
510(k) summary PDF not indicated by FDA
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