|
Device |
laparoscope, general & plastic surgery |
Definition |
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). |
Product Code | GCJ |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADVANCED MEDICAL DESIGN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED SURGICAL CONCEPTS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APPLIED MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APPLIED MEDICAL RESOURCES CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APPLIED MEDICAL RESOURCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAXTER HEALTHCARE CORPORTATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEARCAM, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANNIK |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEROYAL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELMED INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOCLOT PLUS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENLIGHTENVUE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FENGH MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJIFILM CORPORATON |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJIFILM NEW DEVELOPMENT U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENICON, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU TK MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUMAN EXTENSION LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUMAN XTENSIONS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTUITIVE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KARL STORZ ENDOSCOPY AMERICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY-AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LAZURITE HOLDINGS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEXINGTON MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LG ELECTRONICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIVSMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LSI SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAQUET CARDIOVASCULAR, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MARINER ENDOSURGERY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDEON BIODESIGN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDEON BIODESIGN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROMEDICS INC. (D/B/A NORDSON MEDICAL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NDS SURGICAL IMAGING, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOSURGICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW VIEW SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVADAQ TECHNOLOGIES ULC (NOW A PART OF STRYKER) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVATECH S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OMEC MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISTINE SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROGRESSIVE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIVITA MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIVITA MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEJONG MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIDAM S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH AND NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONY ELECTRONICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STANDARD BARIATRICS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGICAL INNOVATIONS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYMMETRY SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMAX MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WICKIMED(HUIZHOU)MEDICAL EQUIPMENT MANUFACTURING CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WUXI SHUKANG MEDICAL APPLIANCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XENOCOR, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
XODUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2017 |
3467 |
3467 |
2018 |
2562 |
2562 |
2019 |
2578 |
2578 |
2020 |
2620 |
2620 |
2021 |
3430 |
3430 |
2022 |
1268 |
1268 |
|
|
|
|