Stryker SDC3 HD Information Management System
FDA 510(k) K121893 · Stryker Endoscopy
510(k) numberK121893
Submission
- Device name
- Stryker SDC3 HD Information Management System
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- June 29, 2012
- Decision date
- September 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GCJ
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| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | 07/30/2026SE |
| K253602 | Precision S 4K SinuscopeGWG · Traditional | 06/04/2026SE |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | 05/28/2026SE |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…GCJ · Special | 02/18/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | 02/12/2026SE |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…GCJ · Special | 01/13/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | 12/31/2025SE |
| K252010 | SPY LaparoscopeGCJ · Special | 07/24/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | 07/18/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | 05/23/2025SE |
Questions and answers
When was Stryker SDC3 HD Information Management System cleared by the FDA?
Stryker SDC3 HD Information Management System (K121893) received a 510(k) decision of Substantially Equivalent on September 5, 2012, 68 days after the submission was received.
What is the product code of K121893?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.