Medical device manufacturer
Olympus Medical Systems Corporation
Olympus Medical Systems Corporation holds 185 FDA 510(k) clearances across 49 product codes. Median elapsed review time is 120 days. openFDA lists no recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 185
- Product codes
- 49
- Median review
- 120 days
- Recall records
- 0
How does FDA spell Olympus Medical Systems Corporation?
FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| OLYMPUS MEDICAL SYSTEMS CORP. | device/registrationlisting | normalised |
| Olympus Medical Systems Corp. | device/510k | normalised |
| Olympus Medical Systems Corporation | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Olympus Medical Systems Corporation file in?
49 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 19 | 143 days | |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 10 | 203 days | |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 9 | 78 days | |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 8 | 147 days | |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 8 | 90 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 8 | 135 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 229 days | |
| FCG | Biopsy Needle | 7 | 97 days | |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 7 | 155 days | |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 7 | 142 days | |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 6 | 117 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 6 | 176 days | |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 6 | 58 days | |
| FEB | Accessories, Cleaning, For Endoscope | 5 | 111 days | |
| KGE | Forceps, Biopsy, Electric | 4 | 116 days | |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | 4 | 115 days | |
| PKL | Hemostatic Metal Clip For The Gi Tract | 4 | 90 days | |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 3 | 90 days | |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 3 | 90 days | |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 | 241 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 101 days | |
| HIF | Insufflator, Laparoscopic | 3 | 113 days | |
| KTI | Bronchoscope Accessory | 3 | 61 days | |
| LFL | Instrument, Ultrasonic Surgical | 3 | 51 days | |
| LQR | Dislodger, Stone, Biliary | 3 | 106 days |
Showing the 25 they file in most, of 49.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Olympus Medical Systems Corporation had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Olympus Medical Systems Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | GEI | 196 | |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | FET | 69 | |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | PKL | 90 | |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | EOQ | 269 | |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | EOB | 262 | |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | KGE | 267 | |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | FDT | 94 | |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | FDX | 262 | |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | KNS | 76 | |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | OWN | 196 |
Source: openFDA device/510k · retrieved
Where is Olympus Medical Systems Corporation registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Olympus Medical Systems Corporation files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.