Company ยท US
The Olympus Optical Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2003. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 5 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 4 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 3 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 |
| GWG | Endoscope, Neurological | 2 |
| ODA | Endoscopic Central Control Unit | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FCG | Biopsy Needle | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| HIF | Insufflator, Laparoscopic | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
| HRX | Arthroscope | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2003 | K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. | EOQ |
| Oct 3, 2003 | K032066 | SONOSURG SYSTEM The Olympus Optical Co. | LFL |
| Sep 23, 2003 | K031305 | OLYMPUS ULTRASONIC SURGICAL SYSTEM Olympus Optical Co., Ltd. | LFL |
| Jul 24, 2003 | K031648 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V Olympus Optical Co., Ltd. | EOB |
| Jul 16, 2003 | K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE Olympus Optical Co., Ltd., JP | FCL |
| May 9, 2003 | K031347 | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 Olympus Optical Co., Ltd. | ODG |
| Mar 24, 2003 | K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT The Olympus Optical Co. | KNS |
| Mar 12, 2003 | K024138 | HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE Olympus Optical Co., Ltd. | GEI |
| Feb 12, 2003 | K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM The Olympus Optical Co. | LFL |
| Feb 11, 2003 | K021852 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES Olympus Optical Co., Ltd. | GEI |
| Jan 31, 2003 | K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES The Olympus Optical Co. | EOQ |
| Jan 24, 2003 | K022445 | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V Olympus Optical Co., Ltd. | HIH |
| Dec 23, 2002 | K023272 | DISPOSABLE ASPIRATION NEEDLE NA-200H The Olympus Optical Co. | FCG |
| Dec 20, 2002 | K024033 | XTJF-160AF DUODENOVIDEOSCOPE Olympus Optical Co., Ltd. | FDT |
| Dec 19, 2002 | K023280 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES Olympus Optical Co., Ltd. | GEI |
| Nov 29, 2002 | K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES The Olympus Optical Co. | GEI |
| Aug 20, 2002 | K013759 | MSS-28CS-301/701 NEEDLESCOPE Olympus Optical Co., Ltd. | GWG |
| Aug 14, 2002 | K022270 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA Olympus Optical Co., Ltd. | ODA |
| Jul 5, 2002 | K021179 | DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A Olympus Optical Co., Ltd. | OCY |
| Jun 25, 2002 | K014166 | UHI-3 HIGH FLOW INSUFFLATION UNIT Olympus Optical Co., Ltd. | HIF |
| Jun 19, 2002 | K021886 | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P Olympus Optical Co., Ltd. | FDS |
| May 1, 2002 | K021204 | OLYMPUS BF TYPE UM40 Olympus Optical Co., Ltd. | PSV |
| Jan 30, 2002 | K013617 | LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS Olympus Optical Co., Ltd. | GCJ |
| Dec 26, 2001 | K013591 | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. | EOB |
| Sep 25, 2001 | K012074 | XBO1-824-18/19/20 BIOPSY FORCEPS The Olympus Optical Co. | OCZ |
| Aug 10, 2001 | K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 The Olympus Optical Co. | EOQ |
| Aug 10, 2001 | K011484 | OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 Olympus Optical Co., Ltd. | FBK |
| Jul 25, 2001 | K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co. | EOB |
| May 15, 2001 | K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z The Olympus Optical Co. | FDS |
| May 15, 2001 | K011149 | DISPOSABLE BENDING CANNULA PR-233Q The Olympus Optical Co. | ODD |
| Mar 15, 2001 | K010591 | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER Olympus Optical Co., Ltd., JP | ODG |
| Jan 30, 2001 | K002231 | LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd. | FDS |
| Dec 4, 2000 | K002749 | ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D The Olympus Optical Co. | FDF |
| Sep 26, 2000 | K000095 | OLYMPUS SONOSURG TROCAR XT3900 SYSTEM The Olympus Optical Co. | LFL |
| Sep 8, 2000 | K001766 | OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE Olympus Optical Co., Ltd. | FDS |
| May 26, 2000 | K001203 | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT The Olympus Optical Co. | ITX |
| May 9, 2000 | K001241 | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I The Olympus Optical Co. | FDF |
| Mar 30, 2000 | K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co. | FAJ |
| Mar 26, 1999 | K990687 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS Olympus Optical, Co. | PKL |
| Nov 16, 1998 | K982610 | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) Olympus Optical, Co. | ITX |
| Oct 28, 1998 | K982733 | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE The Olympus Optical Co. | ITX |
| Oct 22, 1998 | K982133 | OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT The Olympus Optical Co. | HRX |
| Oct 5, 1998 | K982734 | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE The Olympus Optical Co. | ODG |
| Aug 21, 1998 | K981993 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA The Olympus Optical Co. | ODA |
| Jul 29, 1998 | K971340 | OLYMPUS NEURO ENDOSCOPE Olympus Optical, Co. | GWG |
| Jun 8, 1998 | K981543 | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co. | EOQ |
| May 18, 1998 | K972114 | OLYMPUS SONOSURG SYSTEM The Olympus Optical Co. | LFL |
| Nov 29, 1996 | K962952 | OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) Olympus Optical, Co. | LBK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||