Medical device manufacturer
United States Endoscopy Group, Inc.
United States Endoscopy Group, Inc. holds 94 FDA 510(k) clearances across 35 product codes. Median elapsed review time is 87 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 94
- Product codes
- 35
- Median review
- 87 days
- Recall records
- 0
How does FDA spell United States Endoscopy Group, Inc.?
FDA publishes this company under 2 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 |
|---|---|---|
| UNITED STATES ENDOSCOPY GROUP, INC. | device/registrationlisting | normalised |
| United States Endoscopy Group, Inc. | 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 United States Endoscopy Group, Inc. file in?
35 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 11 | 63 days | |
| FDI | Snare, Flexible | 10 | 38 days | |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 6 | 38 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 6 | 168 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 89 days | |
| FCK | Instrument, Biopsy, Suction | 4 | 29 days | |
| FDX | Endoscopic Cytology Brush | 4 | 20 days | |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 4 | 90 days | |
| OCX | Endoscopic Irrigation/Suction System | 4 | 53 days | |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 54 days | |
| ODC | Endoscope Channel Accessory | 3 | 98 days | |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 | 85 days | |
| FCG | Biopsy Needle | 2 | 32 days | |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 24 days | |
| FEB | Accessories, Cleaning, For Endoscope | 2 | 95 days | |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 2 | 88 days | |
| JXL | Block, Bite | 2 | 129 days | |
| KGE | Forceps, Biopsy, Electric | 2 | 77 days | |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 2 | 87 days | |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 | 29 days | |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | 2 | 27 days | |
| DRC | Trocar | 1 | 89 days | |
| DWP | Dilator, Vessel, Surgical | 1 | 89 days | |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 77 days | |
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | 1 | 382 days |
Showing the 25 they file in most, of 35.
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 United States Endoscopy Group, Inc. 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 United States Endoscopy Group, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K192265 | gi-4000 Electrosurgical Generator | GEI | 274 | |
| K200745 | Lariat, Hot/Cold Snare | FDI | 29 | |
| K192059 | Bio Guard Air/Water & Suction Valves | ODC | 47 | |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | FEQ | 49 | |
| K182909 | Roth Net Retriever Product Line | FDI | 35 | |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | FEQ | 31 | |
| K173650 | AquaShield System CO2- Fujifilm | FEQ | 38 | |
| K172805 | gi-4000 Electrosurgical Generator | GEI | 35 | |
| K163495 | AdvanCE capsule endoscope delivery device | NEZ | 87 | |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear | FDF | 24 |
Source: openFDA device/510k · retrieved
Where is United States Endoscopy Group, Inc. 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 United States Endoscopy Group, Inc. 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.