510(k) K072211
- Device
- INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
- Applicant
- INTUITIVE SURGICAL, INC.
- 510(k) number
- K072211
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-28
- Date received
- 2007-08-09
- 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
- Yes
Applicant Contact#
- Contact
- MICHAEL H YRAMATEGUI
- Address
- 950 Kifer Rd. Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 2031966
- 3014334038
- 3001675293
- 3008517893
- 3012322232
- 1526531
- 3001082453
- 3011649314
- 3012421607
- 3005004799
- 9680845
- 9616024
- 1923569
- 3003394627
- 3015537048
- 1058020
- 1723170
- 3001617766
- 3014290448
- 3004608878
- 1935627
- 3024788684
- 3011577940
- 3020584246
- 3011373951
- 3009539885
- 3043543260
- 2183301
- 3010041430
- 3006846433
- 1057421
- 1926681
- 3003236702
- 1056553
- 2431166
- 3013177549
- 2434839
- 3010687973
- 3013357025
- 3008791019
- 3043226252
- 3007695749
- 3013546462
- 3017949824
- 1058584
- 3011137372
- 3009307953
- 3012085539
- 3005409899
- 3043237009
- 3020767943
- 3022626486
- 3014409963
- 3008959420
- 1450428
- 2916714
- 8010697
- 8030674
- 3021119558
- 1017294
- 3011050570
- 3008693672
- 1043653
- 9617542
- 2024312
- 3011276344
- 1833920
- 9610773
- 3010057495
- 3004153240
- 1418479
- 3006008984
- 3006561161
- 3006948427
- 9612468
- 3010041511
- 1030489
- 3014579188
- 3009513193
- 3008868758
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 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 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 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 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#
summary
FDA Review#
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