GCJ · Laparoscope, General & Plastic Surgery

Device class

Class II

Regulation 876.1500

Total clearances

172

2020-01-08 → 2026-09-11

Last 12 months

Unique sponsors

Definition

What is Laparoscope, General & Plastic Surgery

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).

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.1500

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Stryker	14	0	2023-08-18
Stryker Endoscopy	9	2	2026-02-18
Arthrex, Inc.	7	1	2025-10-16
Guangdong Optomedic Technologies, Inc.	6	1	2025-10-29
Human Xtensions , Ltd.	5	0	2023-06-05
Intuitive Surgical, Inc.	5	2	2026-07-14
Karl Storz Endoscopy America	4	0	2023-06-23
Lg Electronics.Inc	4	1	2026-07-17
Xenocor, Inc.	3	1	2026-02-12
Applied Medical Resources Corp.	3	1	2025-10-31
Karl Storz SE & CO. KG	3	3	2026-09-01
Advanced Surgical Concepts, Ltd.	2	0	2023-09-29
Fujifilm Corporaton	2	0	2021-12-02
Advamedix, GmbH	2	0	2024-11-22
Dannik	2	0	2025-03-12
Olympus Medical Systems Corp.	2	0	2022-03-09
Hangzhou Viction Medical Technology Co.,Ltd	2	0	2025-08-06
Eizo Corporation	2	1	2026-09-11
Asclepion Laser Technologies GmbH	2	0	2024-11-06
Taiwan Surgical Corporation	2	1	2026-06-02
Scivita Medical Technology Co., Ltd.	2	0	2023-01-13
Freyja Healthcare, LLC	2	2	2026-08-13
Schoelly Fiberoptic GmbH	2	0	2024-06-20
Ximedica	2	0	2024-04-01
Lsi Solutions, Inc.	2	0	2024-01-12

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
47562	CPT	—	Medium	CPT for laparoscopic cholecystectomy; laparoscope billing depends on procedure performed
99070	CPT	—	Medium	Laparoscope as reusable instrument typically included in facility charge or billed as supply

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-11	K262397	Eizo Corporation	CuratOR EX2742
2026-09-01	K260884	Karl Storz SE & CO. KG	UNIDRIVE Select System
2026-08-26	K260972	Sony Corporation	OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
2026-08-13	K261139	Freyja Healthcare, LLC	VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
2026-07-24	K253541	Medical Impact	EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
2026-07-17	K261614	Lg Electronics.Inc	LED LCD Monitor (OEV-271H)
2026-07-14	K261249	Intuitive Surgical, Inc.	Universal Seal (5-12 mm)
2026-06-11	K260710	FloShield, Inc.	FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
2026-06-10	K260414	Tech-Image CO., LTD.	Tech-Image Video Endoscope System
2026-06-04	K253994	TroCare, LLC	TroKit Laparoscope Lens Wiper
2026-06-02	K252532	Taiwan Surgical Corporation	Inno-Port Disposable Bladed Trocar
2026-05-26	K260318	Zhejiang Healnoc Technology Co., Ltd.	4K NIR/ICG Imaging System
2026-05-24	K260183	Parallel Robotics, LLC	MediBot Needle Driver Uno
2026-05-19	K252985	Sejong Medical Co., Ltd.	Laport
2026-05-11	K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals
2026-04-30	K252858	Kms Medical Technology Co., Ltd.	4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
2026-04-08	K260197	Suzhou Shenyun Medical Equipment Co., Ltd.	Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
2026-04-08	K260089	Scopix , Ltd.	TL-10 Laparoscopic Scope Cleaner
2026-02-27	K252714	Vigor Medical Technologies , Ltd.	C-Lant Port
2026-02-24	K253978	Intuitive Surgical, Inc.	Universal Seal (5-12 mm)
2026-02-18	K260185	Stryker Endoscopy	1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
2026-02-12	K260177	Xenocor, Inc.	Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)
2026-01-29	K251923	Hangzhou Hawk Optical Electronic Instruments Co., Ltd.	Medical Shaver System (Morcellator) (YSB-IIIA)
2026-01-23	K252957	Ab Medica Sas	Pneumo Dissector Hook
2026-01-13	K254014	Stryker Endoscopy	Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control