FDA 510(k) Applications for Medical Device:
Electrode, Electrosurgical, Active, Urological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K031001 | ACMI CORPORATION |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K971512 | AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST | MINNETONKA | MN | 55343 |
| K991314 | AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST | MINNETONKA | MN | 55343 |
| K022543 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K031029 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K955531 | ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2936 |
| K970526 | ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2936 |
| K961069 | ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2936 |
| K962538 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K961841 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K213135 | Chirurgie Innovation |
Z.A. Les Godets, 3 Rue Des Petits Ruisseaux | Verriere le Buisson | 91370 | |
| K163090 | Chirurgie Innovation |
27 PLACE VICTOR SCHOELCHER | MASSY | F-91300 | |
| K973820 | CIRCON CORP. |
6500 HOLLISTER AVE. | SANTA BARBARA | CA | 93117-3019 |
| K210394 | Dornier MedTech America Inc. |
1155 Roberts Blvd, Suite 100 | Kennesaw | GA | 30144 |
| K965118 | ENDOCARE, INC. |
18 TECHNOLOGY DR., SUITE 134 | IRVINE | CA | 92718 |
| K974516 | ENDOLAP, INC. |
3012 MERCY DR. | ORLANDO | FL | 32808 |
| K974515 | ENDOLAP, INC. |
3012 MERCY DR. | ORLANDO | FL | 32808 |
| K093181 | GYRUS ACMI, INC. |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K120567 | GYRUS ACMI, INC. |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K961702 | KARL STORZ ENDOSKOP GMBH |
600 CORPORATE POINTE | CULVER CITY | CA | 90230 |
| K061541 | KSEA |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K962653 | MICROGYN CORP. |
125 JOHN HANCOCK RD. | TAUNTON | MA | 02780 |
| K091511 | MODERN MEDICAL EQUIPMENT MFG., LTD. |
35 TAI LIN PAI RD. | KWAI CHUNG, HONG KONG | ||
| K954710 | NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. | ELGIN | IL | 60123 |
| K970717 | NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. | ELGIN | IL | 60123 |
| K120418 | OLYMPUS WINTER & IBE GMBH |
3500 CORPORATE PKWAY | CENTER VALLEY | PA | 18034-0610 |
| K102781 | OLYMPUS WINTER & IBE GMBH |
3500 CORPORATE PKWAY | CENTER VALLEY | PA | 18034-0610 |
| K152092 | Olympus Winter & Ibe GmbH |
Kuehnstrasse 61 | Hamburg | 22045 | |
| K210651 | Olympus Winter & Ibe GmbH |
Kuehnstr. 61 | Hamburg | 22045 | |
| K171965 | Olympus Winter & Ibe GmbH |
Kuehnstrasse 61 | Hamburg | 22045 | |
| K100275 | OLYMPUS WINTER & IBE GMBH |
3500 CORPORATE PKWAY | CENTER VALLEY | PA | 18034-0610 |
| K050454 | OMNITECH SYSTEMS, INC. |
456 SOUTH CAMBELL, BLDG. C | VALPARAISO | IN | 46385 |
| K151976 | OMNITECH SYSTEMS, INC. |
450 SOUTH CAMPBELL ST. SUITE #2 | VALPARAISO | IN | 46385 |
| K965093 | OMNITECH SYSTEMS, INC. |
456 SOUTH CAMBELL, BLDG. C | VALPARAISO | IN | 46385 |
| K964365 | OMNITECH SYSTEMS, INC. |
456 SOUTH CAMBELL, BLDG. C | VALPARAISO | IN | 46385 |
| K050488 | PROSURG, INC. |
2193 TRADE ZONE BLVD. | SAN JOSE | CA | 95131 |
| K953983 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K053322 | ROEI MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K050910 | ROEI MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K953453 | SYMBIOSIS CORP. |
8600 N.W. 41 ST. | MIAMI | FL | 33166 |
| K974637 | XIMED/PROSURE/INJECTX |
2195 TRADE ZONE BLVD. | SAN JOSE | CA | 95131 |
| K981256 | XIMED/PROSURE/INJECTX |
2193 TRADE ZONE BLVD. | SAN JOSE | CA | 95131 |
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