Company ยท US
Symbiosis Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1996. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| GAA | Needle, Aspiration And Injection, Disposable | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 |
| FCL | Forceps, Biopsy, Non-Electric | 3 |
| GBX | Catheter, Irrigation | 2 |
| HRX | Arthroscope | 2 |
| KGE | Forceps, Biopsy, Electric | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 |
| FHP | Needle, Pneumoperitoneum, Simple | 1 |
| GCB | Needle, Catheter | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 |
| GSS | Antisera, Fluorescent, Pseudomonas Aeruginosa | 1 |
| HFB | Forceps, Biopsy, Gynecological | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 |
| KNW | Instrument, Biopsy | 1 |
| LRC | Instrument, Ent Manual Surgical | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 1996 | K955119 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES Symbiosis Corp. | HIH |
| Jan 17, 1996 | K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES Symbiosis Corp. | FAS |
| Oct 6, 1995 | K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES Symbiosis Corp. | KNF |
| Jul 5, 1995 | K952432 | SYMBIOSIS BIPOLAR FORCEPS Symbiosis Corp. | GEI |
| Apr 10, 1995 | K951387 | SYMBIOSIS BIPOLAR SCISSORS Symbiosis Corp. | GCJ |
| Feb 3, 1995 | K950286 | SYMBIOSIS BIPOLAR SCISSORS Symbiosis Corp. | GCJ |
| Jan 20, 1995 | K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS Symbiosis Corp. | FCL |
| Jul 28, 1994 | K930773 | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS Symbiosis Corp. | HFB |
| Jun 22, 1994 | K941426 | SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE Symbiosis Corp. | GEI |
| Mar 15, 1994 | K932266 | SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN Symbiosis Corp. | KGE |
| Feb 28, 1994 | K931957 | SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS Symbiosis Corp. | FCL |
| Dec 6, 1993 | K924016 | SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST. Symbiosis Corp. | HRX |
| Aug 9, 1993 | K932265 | SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND Symbiosis Corp. | FCL |
| Jul 22, 1993 | K931793 | SYMBIOSIS ENT SURGICAL INSTRUMENTS Symbiosis Corp. | LRC |
| Jul 6, 1993 | K930160 | ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE Symbiosis Corp. | GDM |
| Jul 2, 1993 | K930158 | BONE MARROW BIOPSY PROCEDURE TRAY Symbiosis Corp. | GAA |
| Jun 7, 1993 | K926109 | FLUID DRAINAGE TRAY Symbiosis Corp. | GBX |
| May 26, 1993 | K925707 | INSTRUMENT, MANUAL, GENERAL SURGICAL Symbiosis Corp. | GEI |
| Apr 20, 1993 | K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE Symbiosis Corp. | GAA |
| Mar 16, 1993 | K924017 | SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST. Symbiosis Corp. | HRX |
| Feb 23, 1993 | K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE Symbiosis Corp. | GAA |
| Feb 23, 1993 | K925410 | SYMBIOSIS HEMOSTATIC WAND Symbiosis Corp. | GCJ |
| Jan 12, 1993 | K924702 | TURKEL ABDOMINAL PARACENTESIS SYSTEM Symbiosis Corp. | GBX |
| Nov 25, 1992 | K923563 | SYMBIOSIS SUCTION-IRRIGATOR Symbiosis Corp. | GEI |
| Aug 26, 1992 | K920762 | BIOSPSY FORCEPS Symbiosis Corp. | OCZ |
| Aug 11, 1992 | K922571 | INSTRUMENT, MANUAL, GENERAL SURGICAL Symbiosis Corp. | GCJ |
| Aug 4, 1992 | K923028 | TURKEL PNEUMOTHORAX KIT Symbiosis Corp. | GCB |
| Jul 30, 1992 | K922614 | TURKEL THORACENTESIS SYSTEM Symbiosis Corp. | GAA |
| Jul 30, 1992 | K921461 | TURKEL THORACENTESIS NEEDLE Symbiosis Corp. | GSS |
| May 31, 1991 | K910831 | ENDOPATH SURGICAL INSTRUMENTS Symbiosis Corp. | GEI |
| May 2, 1991 | K910964 | HOT BIOPSY FORCEPS Symbiosis Corp. | KGE |
| Apr 18, 1991 | K910855 | ENDOPATH VERESS NEEDLE Symbiosis Corp. | FHP |
| Oct 31, 1989 | K895415 | BIOPSY FORCEPS Symbiosis Corp. | EOQ |
| Sep 8, 1989 | K894419 | GASTRO ENTEROLOGICAL BIOPTOME Symbiosis Corp. | KNW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2003 | Symbiosis Corp. Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box. Terminated |
DQX | K933334 |
| Feb 27, 2003 | Symbiosis Corp. Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) proce Terminated |
DQX | K962572 |
| Feb 27, 2003 | Symbiosis Corp. Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length. Terminated |
DQX | K962572 |
| Feb 27, 2003 | Symbiosis Corp. Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length Terminated |
DQX | K960657 |
| Feb 27, 2003 | Symbiosis Corp. Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is s Terminated |
DQX | K962572 |
| Feb 21, 2003 | Symbiosis Corp. Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is pakaged in a Tyvek laminate pouch. The pouch as Terminated |
None listed |