Trocar
FDA 510(k) K914377 · O.R. Concepts, Inc.
510(k) numberK914377
Submission
- Device name
- Trocar
- Applicant
- O.R. Concepts, Inc.
Roanoke, TX, US - Received
- October 1, 1991
- Decision date
- October 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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).
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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 |
|---|---|---|
| K941337 | Flowgun Electrocautery ProbesGEI · Traditional | 08/17/1994SE |
| K935971 | Flowgun Electrocautery ProbesGEI · Traditional | 05/16/1994SE |
| K935970 | Flowgun Electrocautery Probe HandleGEI · Traditional | 05/16/1994SE |
| K935645 | Flowgun Reusable Irrigation ProbesGCJ · Traditional | 03/07/1994SE |
| K926242 | Orc Endoscopic Monopolar Electrosurgical ProbeGEI · Traditional | 10/15/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | 09/24/1993SE |
| K922197 | Insufflator Tubing KitHIG · Traditional | 09/24/1993SE |
| K932449 | Dr. FogOCT · Traditional | 08/11/1993SE |
| K925147 | Orc 10.0MM Suction ProbeGCJ · Traditional | 06/25/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | 05/21/1993SE |
Questions and answers
When was Trocar cleared by the FDA?
Trocar (K914377) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 29 days after the submission was received.
What is the product code of K914377?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.