FDA Product Code
FDA Product Code FCG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1075
510(k) Clearances — 133 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K936194 | COAXIAL BIOPSY NEEDLE | Bard Gynecology and Radiology | 1994-03-22 | Traditional | PDF ↗ |
| K915801 | BIP-COAX-SYSTEM | Uni-Quatro Industries Canada, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K934370 | BIP BIOPSY NEEDLE MODIFICATION | Bip USA, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K934356 | WILSON-COOK GI ASPIRATION NEEDLE | Wilson-Cook Medical, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K926559 | PROACT BIOPSY NEEDLE ENCHANCEMENTS | Proact, Ltd. | 1993-03-22 | Traditional | PDF ↗ |
| K924271 | CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES | Core Medical, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K914732 | CORE MEDICAL BIOPSY NEEDLE | Core Medical, Inc. | 1992-01-07 | Traditional | PDF ↗ |
| K910720 | BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER | C.R. Bard, Inc. | 1991-06-10 | Traditional | PDF ↗ |
| K911397 | HYPODERMIC NEEDLES, SINGLE LUMEN | Popper & Sons, Inc. | 1991-05-20 | Traditional | PDF ↗ |
| K905556 | HIGH SPEED CORE CUT BIOPSY GUN | Uni-Quatro Industries Canada, Inc. | 1991-03-08 | Traditional | PDF ↗ |
| K902320 | BAUER FLEXI-TEMNO BIOPSY NEEDLE | Proact, Ltd. | 1990-10-01 | Traditional | PDF ↗ |
| K902319 | BAUER TEMNO BIOPSY NEEDLE | Proact, Ltd. | 1990-09-06 | Traditional | PDF ↗ |
| K896932 | INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE | The Witmoore Group, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K895725 | BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES | Interson Corp. | 1989-11-06 | Traditional | PDF ↗ |
| K895897 | MANAN PROSTATIC BIOPSY NEEDLE | Manan Medical Products, Inc. | 1989-10-18 | Traditional | PDF ↗ |
| K892068 | TRT (ACUSON) NEEDLE GUIDE KIT, STERILE | Amedic USA | 1989-08-04 | Traditional | PDF ↗ |
| K891777 | PRO-CUT BIOPSY NEEDLE | Teknar, Inc. | 1989-05-04 | Traditional | PDF ↗ |
| K890203 | ADMS BIOPSY NEEDLE | Advanced Diagnostic Medical Systems, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K890327 | BIOPSY NEEDLE GUIDE ATTACHMENT | Elscint, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K882549 | ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. | Acuson Corp. | 1988-07-21 | Traditional | PDF ↗ |
| K871467 | BIOPSY NEEDLE GUIDE KIT, STERILE | Amedic USA | 1987-08-21 | Traditional | PDF ↗ |
| K854404 | ROTEX SCREW BIOPSY NEEDLE | Meadox Surgimed, Inc. | 1985-12-02 | Traditional | PDF ↗ |
| K854289 | MEDSURG ULTRASOUND BIOPSY TRAY | Medsurg Industries, Inc. | 1985-11-26 | Traditional | PDF ↗ |
| K844993 | COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 | Omnis Surgical, Inc. | 1985-02-28 | Traditional | PDF ↗ |
| K840144 | YAG LASER 8000 GASTROINTESTINAL BLEE | Cooper Medical Corp. | 1984-05-18 | Traditional | PDF ↗ |
| K840354 | MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE | Sherwood Medical Co. | 1984-03-12 | Traditional | PDF ↗ |
| K834249 | MONOJECT SOFT TISSUE BIOPSY NEEDLE | Sherwood Medical Co. | 1984-03-12 | Traditional | PDF ↗ |
| K840157 | MILLEREISEN CURVED BIOPSY NEEDLE | Preventive Medicine Institute | 1984-03-12 | Traditional | PDF ↗ |
| K840168 | WESTERMAN-JENSEN BIOPSY NEEDLE | Popper & Sons, Inc. | 1984-03-12 | Traditional | PDF ↗ |
| K800419 | ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL | A.D.T. Lab Industries | 1980-03-25 | Traditional | PDF ↗ |
| K800416 | ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA) | A.D.T. Lab Industries | 1980-03-25 | Traditional | PDF ↗ |
| K800420 | ADT PERCUTANEOUS NON-DISP. NEEDLE | A.D.T. Lab Industries | 1980-03-25 | Traditional | PDF ↗ |
| K771108 | NEEDLE, CHIBA UNIVERSITY | Johannah Medical Services, Inc. | 1977-07-29 | Traditional | PDF ↗ |
Product code FCG · Class II · Gastroenterology, Urology. Data: openFDA.