FDA Product Code
FDA Product Code GAA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 107 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression Indicator | Pneumeric, Inc. | 2023-03-28 | Traditional | PDF ↗ |
| K102274 | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | Arvik Enterprises/ Mini Lap Technologies | 2011-06-15 | Traditional | PDF ↗ |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | Diametrics Medical, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | Ximed/Prosure/Injectx | 2000-03-01 | Traditional | PDF ↗ |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | Ximed/Prosure/Injectx | 1998-12-11 | Traditional | PDF ↗ |
| K974741 | MANAN ACCURA NEEDLE | Medical Device Technologies, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | Radi Medical Systems AB | 1996-09-11 | Traditional | PDF ↗ |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | 1996-07-19 | Traditional | PDF ↗ |
| K945109 | MONOJECT BONE MARROW BIOPSY TRAYS | Sherwood Medical Co. | 1994-11-14 | Traditional | PDF ↗ |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | Manan Medical Products, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Manan Medical Products, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K930158 | BONE MARROW BIOPSY PROCEDURE TRAY | Symbiosis Corp. | 1993-07-02 | Traditional | PDF ↗ |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | Kirwan Surgical Products, Inc. | 1993-05-07 | Traditional | PDF ↗ |
| K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-04-20 | Traditional | PDF ↗ |
| K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-02-23 | Traditional | PDF ↗ |
| K922614 | TURKEL THORACENTESIS SYSTEM | Symbiosis Corp. | 1992-07-30 | Traditional | PDF ↗ |
| K915417 | KOPAN'S TARGET | Medical Device Technologies, Inc. | 1992-01-14 | Traditional | PDF ↗ |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | Dlp, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K913992 | ASPIRATION/INJECTION NEEDLE | Northgate Technologies, Inc. | 1991-10-30 | Traditional | PDF ↗ |
| K912074 | BONE MARROW BIOPSY TRAY | Manan Medical Products, Inc. | 1991-08-28 | Traditional | PDF ↗ |
| K910036 | SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES | Surgical Technologies, Inc. | 1991-04-04 | Traditional | PDF ↗ |
| K910117 | REDDICK IRRIGATION/ASPIRATION SYSTEM | Ideal Medical, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE | Telemed Systems, Inc. | 1990-05-24 | Traditional | PDF ↗ |
| K897050 | WILSON-COOK LUNG BIOPSY NEEDLE | Wilson-Cook Medical, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K896605 | KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) | National-Standard Medical Products | 1990-01-04 | Traditional | PDF ↗ |
| K896606 | JACKSON FINE NEEDLE ASPIRATION SYSTEM | National-Standard Medical Products | 1990-01-04 | Traditional | PDF ↗ |
| K896019 | MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. | Dlp, Inc. | 1990-01-03 | Traditional | PDF ↗ |
| K895012 | E-Z-EM VACUUM ASPIRATION SYRINGE | E-Z-Em, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K894874 | 14 INCH BULLET POINT NEEDLE | R. J. Doyle, Inc. | 1989-09-22 | Traditional | PDF ↗ |
| K894873 | 16 GA X 10 BULLET POINT NEEDLE | R. J. Doyle, Inc. | 1989-09-22 | Traditional | PDF ↗ |
| K894875 | 20GA X 7-1/2 THREADING BULLET POINT NEEDLE | R. J. Doyle, Inc. | 1989-09-22 | Traditional | PDF ↗ |
| K894872 | 16 GA X 6 BULLET POINT NEEDLE | R. J. Doyle, Inc. | 1989-09-22 | Traditional | PDF ↗ |
| K894326 | THORACENTISIS KIT | Mill-Rose Laboratory | 1989-07-24 | Traditional | PDF ↗ |
| K883014 | MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED | Sherwood Medical Co. | 1988-07-28 | Traditional | PDF ↗ |
| K882105 | CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM | Dianon Systems, Inc. | 1988-07-11 | Traditional | PDF ↗ |
| K880377 | NOVO VIVO MODEL #17140 AND #17135 | Genesis Industries, Inc. | 1988-04-04 | Traditional | PDF ↗ |
| K874000 | PRIA-KIT (TM) PRIAPISM KIT S.S. | Canton Medical, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K873124 | ANCHOR BIOPSY NEEDLE | Anchor Products Co. | 1987-09-08 | Traditional | PDF ↗ |
| K870893 | MEDSURG CHIBA PTC NEEDLE | Medsurg Industries, Inc. | 1987-03-25 | Traditional | PDF ↗ |
| K870896 | NOTCH-NEEDLE, WESCOTT STYLE | Ocean Medical Products, Ltd. | 1987-03-18 | Traditional | PDF ↗ |
| K864800 | NAMIC CHIBA ASPIRATION BIOPSY NEEDLE | North American Instrument Corp. | 1987-02-06 | Traditional | PDF ↗ |
| K864139 | RANFAC CUT BIOPSY NEEDLE | Ranfac, Corp. | 1986-11-05 | Traditional | PDF ↗ |
| K863848 | MANAN BREST TUMOR LOCALIZATION NEEDLE | Manan Manufacturing Co., Inc. | 1986-10-14 | Traditional | PDF ↗ |
| K863326 | BONE MARROW TRAY | Packaging Technologies, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K860582 | TBI NEEDLE | Hobbs Medical, Inc. | 1986-03-04 | Traditional | PDF ↗ |
| K855141 | ANGIOMED FINE NEEDLES AND NEEDLE SET | Angiomed U.S., Inc. | 1986-01-24 | Traditional | PDF ↗ |
| K854579 | HYPODERMIC NEEDLE AND STYLET | Berkley and Co. | 1985-12-17 | Traditional | PDF ↗ |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | Microvasive | 1985-11-13 | Traditional | PDF ↗ |
| K853980 | EROSA DISPOSABLE HYPODERMIC NEEDLE | Rose KG | 1985-10-18 | Traditional | PDF ↗ |
| K852897 | LEE BONE MARROW BIOPSY/ASPIRATION TRAY | Southland Instruments, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K852817 | STERILE, DISPOSABLE NEEDLE | Fabersanitas, S.A. | 1985-07-26 | Traditional | PDF ↗ |
| K852426 | MANAN TROCAR STYLE BIOPSY NEEDLE | Manan Manufacturing Co., Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K852427 | MANAN SPINAL NEEDLE | Manan Manufacturing Co., Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K851953 | HAWKIN NEEDLE | Wilson-Cook Medical, Inc. | 1985-05-17 | Traditional | PDF ↗ |
| K851957 | CHIBA NEEDLE | Wilson-Cook Medical, Inc. | 1985-05-17 | Traditional | PDF ↗ |
| K843925 | GILL'S IRRIGATOR/ASPIRATOR NEEDLE | Concept, Inc. | 1984-11-05 | Traditional | PDF ↗ |
| K843083 | CORMED HUBER POINT NEEDLE | Cormed, Inc., Sub. C.R.Bard, Inc. | 1984-09-05 | Traditional | PDF ↗ |
| K842230 | AIMED DISPOS. INJECTION NEEDLE | Tech-Cons Ltd., Intl. | 1984-08-17 | Traditional | PDF ↗ |
| K842106 | LEE BONE MARROW NEEDLES | Southland Instruments, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K842699 | ISLAM BONE MARROW ASPIRATION NEEDLES | Downs Surgical , Ltd. | 1984-08-02 | Traditional | PDF ↗ |
| K841301 | GARDNER TYPE BONE MARROW NEEDLE | Popper & Sons, Inc. | 1984-06-05 | Traditional | PDF ↗ |
| K840922 | INTRADISCAL THERAPY NEEDLE 18 GAUGE | Dlp, Inc. | 1984-04-24 | Traditional | PDF ↗ |
| K832626 | TOP STERILE DISPOS. HYPODERMIC NEEDLES | Top Surgical Manufacturers Co. | 1983-10-14 | Traditional | PDF ↗ |
| K831392 | TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 | Travenol Laboratories, S.A. | 1983-07-12 | Traditional | PDF ↗ |
| K830378 | STERILE, DISPOSABLE, HYPODERMIC NEEDLES | Abco Dealers, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K821697 | INJECTION ASPIRATING NEEDLES | American Endoscopy, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K821017 | VARIOUS STERILE BIOPSY ASPIRATION NEED | Medsurg Industries, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K821348 | HYPODERMIC NEEDLES & SYRINGES | Medi-Tech, Inc. | 1982-06-10 | Traditional | PDF ↗ |
| K820502 | SILOAM SAVE-A-NEEDLE | Siloam, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K820070 | MSI STERNUM ASPIRATION NEEDLE | Creative Research and Mfg., Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K813460 | CHIBA SKINNY NEEDLE | Ocean Medical Products, Ltd. | 1982-01-07 | Traditional | PDF ↗ |
| K813448 | POTTS-COURNAND STYLE NEEDLE | Ocean Medical Products, Ltd. | 1982-01-07 | Traditional | PDF ↗ |
| K813367 | CUATICO MYELOGRAPHY NEEDLES | Dlp, Inc. | 1982-01-05 | Traditional | PDF ↗ |
| K813368 | DISPOSABLE CHIBA-TYPE NEEDLE | Dlp, Inc. | 1982-01-05 | Traditional | PDF ↗ |
| K811771 | A.D.T. REUSABLE BONE MARROW NEEDLE | Lab Industries, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K810248 | MSI BONE MARROW BIOPSY NEEDLE W/J TIP | Creative Research and Mfg., Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K810076 | PHERESIS NEEDLE ASSEMBLY | Haemonetics Corp. | 1981-03-05 | Traditional | PDF ↗ |
| K801754 | ADT BONE MARROW ASPIRATION NEEDLE | A.D.T. Lab Industries | 1980-08-20 | Traditional | PDF ↗ |
| K801753 | ADT BONE MARROW BIOPSY-ASPIR. NEELDE | A.D.T. Lab Industries | 1980-08-20 | Traditional | PDF ↗ |
| K801457 | ACCU-CORE DISPOSABLE BIOPSY NEEDLE | Medline Industries, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K800412 | ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800408 | ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800411 | ASPIRATION TRAY W/FERRIS DISP. ILLINOIS | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800414 | ADT SOFT TISSUE BIOPSY TRAY | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800410 | ADT BONE MARROW BIOPSY-ASPIRATION TRAY | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800409 | ADT BONE MARROW BIOPSY ASPIRATION TRAY | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800417 | ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL | A.D.T. Lab Industries | 1980-04-28 | Traditional | PDF ↗ |
| K800421 | ADT PERITONEAL LAVAGE TRAY (DISP.) | A.D.T. Lab Industries | 1980-03-25 | Traditional | PDF ↗ |
| K800413 | FERRIS MODIFIED DISP. IL STERNAL-ILIAC | A.D.T. Lab Industries | 1980-03-25 | Traditional | PDF ↗ |
| K800423 | ADT NERVE BLOCK TRAY(DISP.) | A.D.T. Lab Industries | 1980-03-25 | Traditional | PDF ↗ |
| K800415 | ADT MENGHINI TYPE SOFT TISSUE BIOPSY | A.D.T. Lab Industries | 1980-03-25 | Traditional | PDF ↗ |
| K800407 | FERRIS BONE MARROW -NEEDLE-(DISPOSABLE) | A.D.T. Lab Industries | 1980-03-12 | Traditional | PDF ↗ |
| K800153 | EXTEMP/EXTEMP-V | Pharma-Filter, Inc. | 1980-02-06 | Traditional | PDF ↗ |
| K790472 | BURRON VENTED NEEDLE | National Patent Development Corp. | 1979-03-26 | Traditional | PDF ↗ |
| K790060 | NEEDLE II, BURRON FILTER | National Patent Development Corp. | 1979-03-21 | Traditional | PDF ↗ |
| K790142 | NEEDLE, WITH FILTER | National Patent Development Corp. | 1979-02-26 | Traditional | PDF ↗ |
| K790061 | NEEDLE, BURRON FILTER | National Patent Development Corp. | 1979-02-16 | Traditional | PDF ↗ |
| K790079 | NEEDLE, BLOOD COLLECTING | Jelco Laboratories | 1979-02-01 | Traditional | PDF ↗ |
| K781371 | BONE MARROW ASPIRATION KIT | Ferris Mfg. Corp. | 1978-09-20 | Traditional | PDF ↗ |
| K781264 | PAB CONVENIENCE TRAY | Waters Assoc., Inc. | 1978-09-20 | Traditional | PDF ↗ |
Product code GAA · Class I · General, Plastic Surgery. Data: openFDA.