Boehringer Laboratories Liver Retractor
FDA 510(k) K243399 · Boehringer Laboratories, LLC
510(k) numberK243399
Submission
- Device name
- Boehringer Laboratories Liver Retractor
- Applicant
- Boehringer Laboratories, LLC
Phoenixville, PA, US - Received
- October 31, 2024
- Decision date
- July 2, 2025
- 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 |
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| 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 |
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| 510(k) | Device | Decision |
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| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | 08/14/2026SE |
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| K234145 | ViSiGi 3D Gastric Sizing TubeKNT · Special | 01/26/2024SE |
| K151990 | Tissue Removal SystemGCJ · Traditional | 09/11/2015SE |
| K150781 | Tissue Removal PouchGCJ · Traditional | 06/19/2015SE |
| K130483 | Boehringer Gastric Sizing TubeKNT · Traditional | 03/28/2013SE |
| K061788 | Boehringer Laboratories Suction Pump SystemOMP · Traditional | 07/11/2006SE |
| K060277 | Boehringer Laboratories Suction Pump SystemJCX · Traditional | 03/03/2006SE |
| K020538 | Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 SeriesDWL · Traditional | 05/15/2002SE |
| K014187 | Autovac Orthopedic Autotransfusion SystemCAC · Traditional | 02/06/2002SE |
Questions and answers
When was Boehringer Laboratories Liver Retractor cleared by the FDA?
Boehringer Laboratories Liver Retractor (K243399) received a 510(k) decision of Substantially Equivalent on July 2, 2025, 244 days after the submission was received.
What is the product code of K243399?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.