GCJFDA Class 2 · 21 CFR 876.1500
Laparoscope, General & Plastic Surgery
Device family · Gastroenterology, Urology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,414
Manufacturers
164
Flagged signals
12
Adverse-event reports
49,155
Code matrix
| FDA product code | GCJ |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| 2011 | 5 | 79.2 | 311 | |
| Other | 2014 | 5 | 41.6 | 160 |
| Other | 2013 | 4 | 33.3 | 95 |
| Other | 2011 | 4 | 26.1 | 73 |
| Other | 2011 | 14 | 10.3 | 109 |
| Other | 2013 | 14 | 10.3 | 109 |
| Other | 2010 | 29 | 6.1 | 119 |
| Death | 2011 | 3 | 4.5 | 5 |
| Other | 2011 | 3 | 4.4 | 5 |
| Death | 2013 | 4 | 3.5 | 5 |
| Injury | 2010 | 6 | 2.6 | 7 |
| Injury | 2021 | 5 | 2.6 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 49,155 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 47 | 2023 | — |
| Origin Medsystems, Inc. | 34 | 1999 | — |
| Phx Technologies Corp. | 33 | 1994 | — |
| United States Surgical, A Division of Tyco Healthc | 30 | 2006 | — |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 28 | 2008 | — |
| ETHICON ENDO-SURGERY, INC. | 28 | 2003 | — |
| Stryker Endoscopy | 25 | 2026 | — |
| Ethicon, Inc. | 18 | 2005 | — |
| Stryker | 15 | 2023 | — |
| INTUITIVE SURGICAL, INC. | 15 | 2026 | — |
| Applied Medical Resources Corp. | 14 | 2025 | — |
| AESCULAP, INC. | 14 | 2018 | — |
| SOPRO | 13 | 2009 | — |
| Smith & Nephew, Inc. | 13 | 2007 | — |
| United States Endoscopy Group, Inc. | 11 | 1993 | — |
| Olympus America, Inc. | 10 | 1999 | — |
| Covidien | 10 | 2022 | — |
| Applied Medical Resources | 10 | 2014 | — |
| Conmedcorp | 10 | 2000 | — |
| ARTHREX, INC. | 9 | 2025 | — |
| Conmed Corporation | 8 | 2021 | — |
| Davol, Inc. | 6 | 2000 | — |
| Guangdong Optomedic Technologies, Inc. | 6 | 2025 | — |
| OLYMPUS MEDICAL SYSTEMS CORP. | 6 | 2022 | 0.04 |
| Karl Storz Endoscopy | 6 | 2001 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
TL-10 Laparoscopic Scope Cleaner · Scopix , Ltd.510(k) · 2026-04-08
Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) · Suzhou Shenyun Medical Equipment Co., Ltd.510(k) · 2026-04-08
C-Lant Port · Vigor Medical Technologies , Ltd.510(k) · 2026-02-27
Universal Seal (5-12 mm) · Intuitive Surgical, Inc.510(k) · 2026-02-24
1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality · Stryker Endoscopy510(k) · 2026-02-18
Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) · Xenocor, Inc.510(k) · 2026-02-12
Medical Shaver System (Morcellator) (YSB-IIIA) · Hangzhou Hawk Optical Electronic Instruments Co., Ltd.510(k) · 2026-01-29
Pneumo Dissector Hook · Ab Medica Sas510(k) · 2026-01-23
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control · Stryker Endoscopy510(k) · 2026-01-13
KARL STORZ Cholangiography Set · Karl Storz SE & CO. KG510(k) · 2025-11-22
Nuvis® Wireless HD Camera System (Nuvis-2K) · Integrated Endoscopy, Inc.510(k) · 2025-11-20
Kii Structural Balloon Access System · Applied Medical Resources Corp.510(k) · 2025-10-31
3D Laparoscope · Guangdong Optomedic Technologies, Inc.510(k) · 2025-10-29
VereSee Optical Veres Needle and Endoscopic Camera · Freyja Healthcare, LLC510(k) · 2025-10-20
Arthrex Synergy Vision Imaging System · Arthrex, Inc.510(k) · 2025-10-16
Revolve Surgical System · Revolve Surgical, Inc.510(k) · 2025-10-03
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) · Shenzhen Sophway Technology Co., Ltd.510(k) · 2025-10-02
SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System · Surgical Principals, Inc.510(k) · 2025-09-22
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) · Hangzhou Viction Medical Technology Co.,Ltd510(k) · 2025-08-06
Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) · Hangzhou Viction Medical Technology Co.,Ltd510(k) · 2025-08-06
SPY Laparoscope · Stryker Endoscopy510(k) · 2025-07-24
Disposable Trocars · Sinolinks Medical Innovation, Inc.510(k) · 2025-07-11
8 mm Assist Cannula; 12 mm Assist Cannula · Intuitive Surgical, Inc.510(k) · 2025-07-02
Boehringer Laboratories Liver Retractor · Boehringer Laboratories, LLC510(k) · 2025-07-02
Medical Monitor (32HS710S) · Lg Electronics.Inc510(k) · 2025-06-12
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.