510(k) K152951
- Device
- Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope And Camera Sterilization Tray, Camera Sterilization Tray
- Applicant
- PARAGON MEDICAL, INC.
- 510(k) number
- K152951
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-28
- Date received
- 2015-10-06
- 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
- MIKE GOSMEYER
- Address
- 8 Matchett Industrial Park Dr. Pierceton IN US 46562 46562
FDA Registration Numbers#
- 3003990090
- 3014615028
- 3003394627
- 3012421607
- 1221934
- 3020767943
- 3019878714
- 2248608
- 2183301
- 3011649314
- 3014409963
- 3043237009
- 3043164947
- 9680845
- 3004080920
- 1032347
- 3013188547
- 3011824442
- 3006783837
- 1828464
- 1526534
- 3010141593
- 3013247477
- 3014579188
- 1319130
- 3005282635
- 3010393565
- 3013546462
- 3009539885
- 3003477135
- 2020550
- 3011137372
- 2936485
- 3024788684
- 3010707607
- 2027467
- 9611959
- 3010202439
- 3005004799
- 3015537048
- 3007695749
- 3003120897
- 1057421
- 2081135
- 3038718579
- 1056553
- 3008114965
- 3002808270
- 3043543260
- 3033708818
- 1526531
- 1053306
- 9610617
- 1834379
- 3021119558
- 3006008984
- 2919128
- 3003790304
- 2027754
- 3015895045
- 1833920
- 2020394
- 9610773
- 3004153240
- 3009513193
- 3012236936
- 2424366
- 1416980
- 3036622014
- 1720499
- 3008693672
- 3006113180
- 2134470
- 3008534770
- 3014191428
- 3014553709
- 3038549074
- 3008864603
- 3013177549
- 2435946
Source Documents#
Other 510(k) Records For Product Code KCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 |
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