Panels › Gastroenterology, Urology › Product code FCG · Class 2
Biopsy Needle
Regulation 876.1075
0510(k)s in 12 months (133 all time)
0recalls in 12 months (54 all time)
51recalls that name a 510(k)
Top companies in FCG
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 5 | 24 |
| Bard Peripheral Vascular Inc | 0 | 8 |
| Cook Ireland, Ltd. | 7 | 0 |
| Medi-Globe Corp. | 7 | 0 |
| Olympus Medical Systems Corp. | 7 | 0 |
| Wilson-Cook Medical, Inc. | 5 | 1 |
| Aomori Olympus Co., Ltd. | 0 | 5 |
| Medtronic | 0 | 5 |
| H.S. Hospital Service S.R.L. | 4 | 0 |
| H.S. Hospital Services S.P.A. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 1994 | K936194 | COAXIAL BIOPSY NEEDLE Bard Gynecology and Radiology | FCG |
| Mar 11, 1994 | K915801 | BIP-COAX-SYSTEM Uni-Quatro Industries Canada, Inc., CA | FCG |
| Mar 7, 1994 | K934370 | BIP BIOPSY NEEDLE MODIFICATION Bip USA, Inc. | FCG |
| Jan 7, 1994 | K934356 | WILSON-COOK GI ASPIRATION NEEDLE Wilson-Cook Medical, Inc. | FCG |
| Mar 22, 1993 | K926559 | PROACT BIOPSY NEEDLE ENCHANCEMENTS Proact, Ltd. | FCG |
| Nov 23, 1992 | K924271 | CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES Core Medical, Inc. | FCG |
| Jan 7, 1992 | K914732 | CORE MEDICAL BIOPSY NEEDLE Core Medical, Inc. | FCG |
| Jun 10, 1991 | K910720 | BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER C.R. Bard, Inc. | FCG |
| May 20, 1991 | K911397 | HYPODERMIC NEEDLES, SINGLE LUMEN Popper & Sons, Inc. | FCG |
| Mar 8, 1991 | K905556 | HIGH SPEED CORE CUT BIOPSY GUN Uni-Quatro Industries Canada, Inc., CA | FCG |
| Oct 1, 1990 | K902320 | BAUER FLEXI-TEMNO BIOPSY NEEDLE Proact, Ltd. | FCG |
| Sep 6, 1990 | K902319 | BAUER TEMNO BIOPSY NEEDLE Proact, Ltd. | FCG |
| Jun 22, 1990 | K896932 | INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE The Witmoore Group, Inc. | FCG |
| Nov 6, 1989 | K895725 | BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES Interson Corp. | FCG |
| Oct 18, 1989 | K895897 | MANAN PROSTATIC BIOPSY NEEDLE Manan Medical Products, Inc. | FCG |
| Aug 4, 1989 | K892068 | TRT (ACUSON) NEEDLE GUIDE KIT, STERILE Amedic USA, SE | FCG |
| May 4, 1989 | K891777 | PRO-CUT BIOPSY NEEDLE Teknar, Inc. | FCG |
| Mar 8, 1989 | K890327 | BIOPSY NEEDLE GUIDE ATTACHMENT Elscint, Inc. | FCG |
| Mar 8, 1989 | K890203 | ADMS BIOPSY NEEDLE Advanced Diagnostic Medical Systems, Inc. | FCG |
| Jul 21, 1988 | K882549 | ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. Acuson Corp. | FCG |
| Aug 21, 1987 | K871467 | BIOPSY NEEDLE GUIDE KIT, STERILE Amedic USA | FCG |
| Dec 2, 1985 | K854404 | ROTEX SCREW BIOPSY NEEDLE Meadox Surgimed, Inc. | FCG |
| Nov 26, 1985 | K854289 | MEDSURG ULTRASOUND BIOPSY TRAY Medsurg Industries, Inc. | FCG |
| Feb 28, 1985 | K844993 | COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 Omnis Surgical, Inc. | FCG |
| May 18, 1984 | K840144 | YAG LASER 8000 GASTROINTESTINAL BLEE Cooper Medical Corp. | FCG |
| Mar 12, 1984 | K840354 | MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE Sherwood Medical Co. | FCG |
| Mar 12, 1984 | K840168 | WESTERMAN-JENSEN BIOPSY NEEDLE Popper & Sons, Inc. | FCG |
| Mar 12, 1984 | K840157 | MILLEREISEN CURVED BIOPSY NEEDLE Preventive Medicine Institute | FCG |
| Mar 12, 1984 | K834249 | MONOJECT SOFT TISSUE BIOPSY NEEDLE Sherwood Medical Co. | FCG |
| Mar 25, 1980 | K800420 | ADT PERCUTANEOUS NON-DISP. NEEDLE A.D.T. Lab Industries | FCG |
| Mar 25, 1980 | K800419 | ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL A.D.T. Lab Industries | FCG |
| Mar 25, 1980 | K800416 | ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA) A.D.T. Lab Industries | FCG |
| Jul 29, 1977 | K771108 | NEEDLE, CHIBA UNIVERSITY Johannah Medical Services, Inc. | FCG |
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