510(k) K151450
- Device
- Endoscope Sterilization Tray
- Applicant
- INTUITIVE SURGICAL, INC.
- 510(k) number
- K151450
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-12
- Date received
- 2015-05-29
- 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
- Kunal Gunjal
- Address
- 1266 Kifer Rd. Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 3011649314
- 3015153469
- 2424366
- 3011373951
- 3013546462
- 3013557562
- 3005282635
- 3008812560
- 3006179046
- 8040233
- 1926681
- 1834379
- 3013357025
- 1416980
- 3017820152
- 3003935342
- 3007389669
- 1835444
- 3034676720
- 3026606306
- 2020550
- 2020601
- 3010120135
- 9614404
- 9610612
- 3003418325
- 3015960676
- 3011824442
- 3021119558
- 3008770252
- 3009959868
- 3019878714
- 3014615028
- 2518634
- 1056350
- 3005694091
- 3027665899
- 1053306
- 3008309062
- 3005497913
- 3008791019
- 1417592
- 3012507533
- 3009307953
- 3012055599
- 3013188547
- 1056276
- 9611274
- 3004201263
- 3013247477
- 9617111
- 3015181082
- 3015895145
- 8030674
- 3011795235
- 1032347
- 3004193466
- 3006783837
- 3003477135
- 3005004799
- 1222780
- 1526531
- 3015967359
- 9611959
- 1717344
- 3020767943
- 2183301
- 3013077751
- 3023155873
- 3004464325
- 9611367
- 9612468
- 1418005
- 9616024
- 1723170
- 1828464
- 3017155536
- 3010493171
- 3000270450
- 3008864603
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#
summary
FDA Review#
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