510(k) K180964
- Device
- Endoscope Sterilization Tray
- Applicant
- Intuitive Surgical, Inc.
- 510(k) number
- K180964
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-09-28
- Date received
- 2018-04-12
- 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. Bldg. 101 Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 1723170
- 3009968482
- 1835251
- 1221934
- 1417592
- 3001082453
- 3013247477
- 1450428
- 3008132392
- 3008693672
- 1314417
- 3004491689
- 1834331
- 3008309062
- 2431166
- 3004201263
- 3013111692
- 3010041511
- 2081135
- 9611274
- 1418479
- 3013283620
- 3010057495
- 3015895145
- 3006008984
- 9613277
- 1030489
- 3026606306
- 3005900820
- 3015612252
- 3014003062
- 3008959420
- 3013077751
- 1062741
- 1416980
- 1833920
- 3007367732
- 3010885402
- 3009539885
- 3015537048
- 9611367
- 3012322232
- 3043164947
- 2020394
- 1836161
- 9680735
- 3003604053
- 1056350
- 3014290448
- 2936485
- 3027665899
- 9613348
- 9617111
- 3004080920
- 3027345187
- 9710524
- 3042940623
- 3009110133
- 3003935342
- 3010393565
- 2031966
- 3020584246
- 3010141593
- 9610773
- 3043226252
- 3016438694
- 3008517893
- 1223422
- 3008252251
- 3010772758
- 3006742481
- 1935627
- 3006783837
- 1418005
- 3015181082
- 8020776
- 3011575197
- 2434839
- 1828464
- 8030607
Source Documents#
Other 510(k) Records For Product Code KCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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