|
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
|
ARK SURGICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHEX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASCLEPION LASER TECHNOLOGIES GMBH |
|
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
|
4
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DANNIK |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ELMED INCORPORATED |
|
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
|
GENICON, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGZHOU TK MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUMAN EXTENSION LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUMAN XTENSIONS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INCORE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTUITIVE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KARL STORZ ENDOSCOPY AMERICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KARL STORZ ENDOSCOPY-AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LAZURITE HOLDINGS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEXINGTON MEDICAL INC. |
|
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
|
1
|
MEDEON BIODESIGN, INC. |
|
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
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OMEC MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PLASMATICA LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISTINE SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROGRESSIVE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANTA BARBARA IMAGING SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHOELLY FIBEROPTIC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIVITA MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIVITA MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIDAM S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH AND NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SONY ELECTRONICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STANDARD BARIATRICS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SURGICAL INNOVATIONS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYMMETRY SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIWAN SURGICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THERMASOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMAX MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
US MEDICAL INNOVATIONS, LLC |
|
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
|
2
|
XODUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|