LED LCD Monitor (OEV-271H)
FDA 510(k) K261614 · Lg Electronics.Inc
510(k) numberK261614
Submission
- Device name
- LED LCD Monitor (OEV-271H)
- Applicant
- Lg Electronics.Inc
Gumi-Si, KR - Received
- May 15, 2026
- Decision date
- July 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
| K252532 | Inno-Port Disposable Bladed TrocarGCJ · Traditional | Taiwan Surgical Corporation | 06/02/2026SE |
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| K241402 | Medical Monitor (32HR734S)GCJ · Traditional | 08/12/2024SE |
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| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713DPGY · Special | 08/15/2023SE |
| K230845 | 32HL512D, 31HN713D, 32HQ713DPGY · Special | 04/27/2023SE |
| K223423 | 32HQ713DPGY · Traditional | 03/01/2023SE |
Questions and answers
When was LED LCD Monitor (OEV-271H) cleared by the FDA?
LED LCD Monitor (OEV-271H) (K261614) received a 510(k) decision of Substantially Equivalent on July 17, 2026, 63 days after the submission was received.
What is the product code of K261614?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.