Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GWG — Predicate Candidate Screening
93 FDA 510(k) clearances under this product code; the 50 most recent screened below.
118 daysmedian FDA review time
322 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | 2026-06-04 | 198 | 0 |
| K253679 | Hydro Irrigation System | Stryker Instruments | 2026-05-08 | 168 | 0 |
| K243429 | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | 2025-05-21 | 197 | 0 |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® S | Integra LifeSciences Corporation | 2025-04-09 | 28 | 0 |
| K233391 | cCeLL - In vivo | VPIX Medical, Inc. | 2024-08-21 | 324 | 0 |
| K223615 | Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC | 2023-11-21 | 351 | 0 |
| K232618 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2023-10-27 | 59 | 1 |
| K230125 | Neuroblade System | Clearmind Biomedical | 2023-10-13 | 269 | 0 |
| K232159 | QEVO System | Carl Zeiss Meditec, AG | 2023-09-21 | 63 | 0 |
| K222735 | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | 2023-07-28 | 322 | 0 |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM Sa | Stryker | 2021-08-06 | 106 | 0 |
| K210251 | ClearPath Disposable Introducer | Clearmind Biomedical | 2021-04-02 | 63 | 0 |
| K200925 | Clarus Peel-Away Introducer Sheath | Clarus Medical, LLC | 2021-03-18 | 345 | 0 |
| K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | 2020-11-27 | 196 | 0 |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope Sys | Rebound Therapeutics | 2020-11-04 | 125 | 1 |
| K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019-12-06 | 148 | 0 |
| K190719 | Artemis Eye System | Penumbra, Inc. | 2019-08-30 | 163 | 0 |
| K182211 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2019-01-18 | 156 | 0 |
| K181731 | MR Compatible Aspiration Kit | Mri Interventions, Inc. | 2018-11-20 | 144 | 0 |
| K181116 | CONVIVO | Carl Zeiss Meditec, AG | 2018-10-25 | 181 | 0 |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | 2018-05-22 | 111 | 0 |
| K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018-04-17 | 89 | 0 |
| K170667 | QEVO System with KINEVO 900 | Carl Zeiss Meditec, AG | 2017-08-18 | 165 | 0 |
| K171332 | Artemis Neuro Evacuation Device | Penumbra, Inc. | 2017-08-14 | 98 | 0 |
| K170462 | KARL STORZ ShuntScope | KARL STORZ Endoscopy-America, Inc. | 2017-05-16 | 90 | 0 |
| K162880 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017-03-16 | 153 | 0 |
| K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2016-09-17 | 150 | 0 |
| K152699 | Apollo System | Penumbra, Inc. | 2016-03-17 | 178 | 0 |
| K142315 | MINOP Disposable Introducer 26F | Aesculap, Inc. | 2014-11-14 | 87 | 0 |
| K132931 | APOLLO SYSTEM | Penumbra, Inc. | 2014-01-17 | 121 | 0 |
| K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | 2013-07-16 | 60 | 0 |
| K081102 | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | 2008-05-29 | 42 | 1 |
| K072410 | KSEA CLEARVISION II, MODEL 40334120 | KARL STORZ Endoscopy-America, Inc. | 2008-05-09 | 256 | 0 |
| K061135 | MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME0 | Aesculap | 2006-07-11 | 78 | 0 |
| K052745 | ASSISTO ARM SYSTEMS | Geomed Medizin-Technik GmbH & Co. | 2005-11-23 | 54 | 1 |
| K043128 | OLYMPUS ENDOARM | Olympus Corporation | 2004-12-21 | 39 | 0 |
| K031858 | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHE | Richard Wolf Medical Instruments Corp. | 2004-07-29 | 409 | 0 |
| K022198 | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, | Richard Wolf Medical Instruments Corp. | 2003-03-21 | 259 | 0 |
| K020507 | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND | Olympus Winter & Ibe GmbH | 2002-10-08 | 235 | 0 |
| K013759 | MSS-28CS-301/701 NEEDLESCOPE | Olympus Optical Co., Ltd. | 2002-08-20 | 280 | 0 |
| K021050 | KSEA NEUROENDOSCOPES AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2002-06-26 | 86 | 0 |
| K014149 | PAEDISCOPE, MODEL # P010A AND PF011A | Aesculap, Inc. | 2002-03-18 | 90 | 0 |
| K010341 | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2 | Medtronic PS Medical | 2001-04-20 | 74 | 2 |
| K003914 | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSOR | Medtronic PS Medical | 2001-02-22 | 65 | 0 |
| K002572 | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001 | Medtronic PS Medical | 2000-11-16 | 90 | 0 |
| K002704 | KSEA MINIATURE NEUROENDOSCOPE | KARL STORZ Endoscopy-America, Inc. | 2000-11-03 | 65 | 0 |
| K002788 | KSEA NEURO-FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | 2000-10-23 | 46 | 0 |
| K002330 | NAVIGUS PEEL AWAY INTRODUCER | Image-Guided Neurologics, Inc. | 2000-10-18 | 78 | 0 |
| K001630 | KSEA BIPOLAR COAGULATING ELECTRODES | Karl Storz Endoscopy | 2000-07-19 | 54 | 0 |
| K993568 | MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L | Machida Endoscope Co., Ltd. | 2000-03-13 | 144 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda