FDA 510(k) Applications Submitted by MIKE GU
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140074 |
01/13/2014 |
HYGEDENT ALGINATE IMPRESSION MATERIAL |
HYGEDENT INC |
| K140195 |
01/27/2014 |
SURGICAL DRAPE |
GRIFFITH-LUCAS LLC |
| K140228 |
01/30/2014 |
DISPOSABLE TRACHEAL TUBE |
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD |
| K140233 |
01/30/2014 |
ULTRASONIC SCALER |
NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. |
| K140237 |
01/30/2014 |
DISPOSABLE NEBULIZER SET |
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD |
| K120475 |
02/16/2012 |
ANESTHESIA CONDUCTION NEEDLES |
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD |
| K131006 |
04/11/2013 |
ANESTHESIA CONDUCTION NEEDLES |
LCCS PRODUCTS LIMITED |
| K140943 |
04/14/2014 |
MASTRO PLUS BALLOON IN-DEFLATION DEVICE |
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. |
| K131389 |
05/14/2013 |
JUSHA-C31 MEDICAL DISPLAY |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
| K131390 |
05/14/2013 |
JUSHA-M52C MEDICAL DISPLAY |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
| K131391 |
05/14/2013 |
JUSHA-M32 MEDICAL DISPLAY |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
| K141467 |
06/03/2014 |
SURGICAL GOWN |
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L |
| K131817 |
06/20/2013 |
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. |
| K131837 |
06/20/2013 |
CO2 FRACTIONAL LASER |
BEIJING HONKON TECHNOLOGIES CO., LTD |
| K131838 |
06/20/2013 |
DIODE LASER FOR HIAR REMOVAL |
BEIJING HONKON TECHNOLOGIES CO., LTD |
| K132882 |
09/13/2013 |
ELECTRIC BREAST PUMP |
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD |
| K123435 |
11/07/2012 |
IPL THERAPY SYSTEM |
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD |
| K133975 |
12/26/2013 |
MSA100 PEAK FLOW METER |
BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD |
| K003883 |
12/15/2000 |
MOLINA ORBITAL MALAR DISTRACTOR |
KLS-MARTIN L.P. |
| K230033 |
01/05/2023 |
Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical Inc. |
| K240502 |
02/21/2024 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical Inc. |
| K240852 |
03/28/2024 |
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) |
Intuitive Surgical, Inc. |
| K131962 |
06/27/2013 |
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
| K242318 |
08/05/2024 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
| K182371 |
08/31/2018 |
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
| K243714 |
12/02/2024 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
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