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Panels › Gastroenterology, Urology › Product code FBK · Class 2

Endoscopic Injection Needle, Gastroenterology-Urology

Regulation 876.1500

3510(k)s in 12 months (89 all time)
1recalls in 12 months (43 all time)
38recalls that name a 510(k)
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Top companies in FBK

Company510(k)sRecalls
Aomori Olympus Co., Ltd.020
Hobbs Medical, Inc.015
Boston Scientific Corp43
Carbon Medical Technologies, Inc.50
Wilson-Cook Medical, Inc.41
Advanced Uroscience, Inc.30
Enteric Medical Technologies30
Mill-Rose Laboratory30
Olympus Medical Systems Corp.30
Uroplasty, Inc.30
Decided510(k)Device and applicantCode
Oct 25, 2002K022484COOK INJECTION NEEDLE
Cook Urological, Inc.
FBK
May 31, 2002K013712ENTERYX INJECTOR
Enteric Medical Technologies
FBK
Nov 2, 2001K012977VARICES INJECTION NEEDLE
Endo-Therapeutics, Inc.
FBK
Aug 10, 2001K011484OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
Olympus Optical Co., Ltd.
FBK
May 16, 2001K010448HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
Horizons Intl. Corp.
FBK
Nov 22, 2000K002778ENTERIC INJECTION CATHETER WITH IRRIGATION
Enteric Medical Technologies, Inc.
FBK
Nov 16, 2000K002573ADVANCED UROSCIENCE INNERSHEATH
Advanced Uroscience, Inc.
FBK
Jul 31, 2000K002323ADVANCED UROSCIENCE INJECTION NEEDLE
Advanced Uroscience, Inc.
FBK
Jun 30, 2000K001146GENYX FLEXIBLE INJECTION NEEEDLE
Geny Medical, Inc.
FBK
Apr 13, 2000K000646DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
Enteric Medical Technologies
FBK
Jun 18, 1999K990996GENYX MEDICAL INJECTION NEEDLE
Genyx Medical, Inc.
FBK
Dec 11, 1998K983765INJECTION NEEDLE PROBE/DEVICE-TUNIS
Ximed/Prosure/Injectx
FBK
Oct 26, 1998K982890ADVANCED UROSCIENCE INJECTION NEEDLE
Advanced Uroscience, Inc.
FBK
Jul 15, 1996K961846NEEDLE CATHETER
Boston Scientific Corp
FBK
May 1, 1996K960519MARTECH ENDOSCOPIC INJECTION NEEDLE
Martech Medical Products, Inc.
FBK
Feb 29, 1996K955558GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES
Medi-Globe Corp.
FBK
Dec 22, 1995K954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
Mill-Rose Laboratory
FBK
Aug 18, 1995K953441RIZA-RIBE NEEDLE
R-Med, Inc.
FBK
Aug 2, 1995K953338INJECTION NEEDLE
Boston Scientific Corp
FBK
May 12, 1995K951648MIST ENDOSCOPIC NEEDLES
Mist, Inc.
FBK
Mar 21, 1995K950976KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
KARL STORZ Endoscopy-America, Inc.
FBK
Jun 2, 1994K941305WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE
Wilson-Cook Medical, Inc.
FBK
Dec 1, 1993K933815BARD ENDOSCOPIC INJECTION SYSTEM
C.R. Bard, Inc.
FBK
Feb 8, 1993K921800COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
Mill-Rose Laboratory
FBK
Nov 25, 1992K924102NEEDLE
United States Endoscopy Group, Inc.
FBK
Dec 5, 1991K914496SCLEROTHERAPY NEEDLE
Surgitek Medical Engineering Corp.
FBK
Oct 15, 1990K903668WILSON-COOK ASPIRATION HANDLE
Wilson-Cook Medical, Inc.
FBK
Aug 24, 1990K902736NM INJECTION NEEDLES
Olympus Corp.
FBK
Jun 18, 1990K901437TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
Telemed Systems, Inc.
FBK
Jan 26, 1990K896424PORGES SCLEROTHERAPY NEEDLES
Porges Corp.
FBK
Dec 21, 1989K894868WILTEK VARICES INJECTION NEEDLE
Wiltek Medical, Inc.
FBK
Dec 8, 1988K883093TRANSENDOSCOPIC ASPIRATION NEEDLE
Endovations
FBK
Jul 21, 1987K872060WASHING/INJECTION NEEDLE
Endovations
FBK
Mar 10, 1987K865086WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
Van-Tec, Inc.
FBK
May 13, 1986K855176TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
Urologic Surgical Devices Corp.
FBK
Jul 26, 1985K851952VARICES INJECTOR
Wilson-Cook Medical, Inc.
FBK
Feb 4, 1984K834403INJECTION NEEDLE
Bobbs Medical, Inc.
FBK
Apr 16, 1982K820973ENDOSCOPIC INJECTION NEEDLE
Mill-Rose Laboratory
FBK
Jul 31, 1981K812057VANCE CYSTOSCOPIC
Vance Products, Inc.
FBK

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