FDA Device Registration & Listing · Stafford Springs, CT, US · Registration 1220592
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GEE | Brush, Biopsy, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-07-26 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2011-01-04 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2008-01-11 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2009-01-30 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-02 |
| LDZ | Fixative, Alcohol Containing | Pathology | Class 1 | 864.4010 | 2021-01-13 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-01-30 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2017-06-26 |
| FDX | Endoscopic Cytology Brush | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-01-30 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2020-02-13 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2016-03-30 |
| FGY | Cannula, Injection | General, Plastic Surgery | Class 1 | 878.4200 | 1984-09-14 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-01-11 |
| FEB | Accessories, Cleaning, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-01-30 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K172288 | Wilson-Cook Medical Inc./Cook Endoscopy | Fusion OMNI Sphincterotome | 2018-04-17 |
| K902734 | Olympus Corp. | PR CANNULAS | 1990-08-22 |
| K781371 | Ferris Mfg. Corp. | BONE MARROW ASPIRATION KIT | 1978-09-20 |
| K761138 | Zeus Scientific, Inc. | FA TISSUE FIXATIVE & WASH SET | 1978-01-06 |
| K842913 | E K Ind., Inc. | WRIGHT STAIN FIXATIVE | 1984-09-07 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0010-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm
Disposable For endoscopy procedures
Ref: 2190 |
| Z-0011-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm
Disposable For endoscopy procedures
Ref: 2191 |
| Z-0012-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Flex-Ez Guide Wire
Disposable For endoscopy procedures
Ref: 3412 |
| Z-0013-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Cytology Brush
Catalog Number: 4204 |
| Z-0014-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Cytology Brush
Catalog Number: 4206 |
| Z-0015-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Polypectomy Snare
Catalog Number: 4563 |
| Z-0016-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Polypectomy Snare
Catalog Number: 4564 |
| Z-0017-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe
Catalog Number: 4620 |
| Z-0018-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle
Catalog Number: 4621 |
| Z-0019-2023 | Hobbs Medical, Inc. | 1 | Hobbs Scope Introducer
Catalog Number: 4650 |
| Z-0020-2023 | Hobbs Medical, Inc. | 2 | Hobbs Posi-Stop Injection Needle
Catalog Number: 4702 |
| Z-0021-2023 | Hobbs Medical, Inc. | 2 | Hobbs Posi-Stop Injection Needle
Catalog Number: 4704 |
| Z-0022-2023 | Hobbs Medical, Inc. | 2 | Hobbs Posi-Stop Injection Needle
Catalog Number: 4712 |
| Z-0023-2023 | Hobbs Medical, Inc. | 2 | Hobbs Posi-Stop Injection Needle
Catalog Number: 4718 |
| Z-0024-2023 | Hobbs Medical, Inc. | 2 | Hobbs Posi-Stop Injection Needle
Catalog Number: 4720 |
| Z-0025-2023 | Hobbs Medical, Inc. | 2 | Hobbs Posi-Stop Injection Needle
Catalog Number: 4722 |
| Z-0026-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4806 |
| Z-0027-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4808 |
| Z-0028-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4814 |
| Z-0029-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4816 |
| Z-0030-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4822 |
| Z-0031-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4824 |
| Z-0032-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4830 |
| Z-0033-2023 | Hobbs Medical, Inc. | 2 | Hobbs Helical Retrieval Basket
Catalog Number: 4832 |
| Z-0034-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Grasping Forceps
Catalog Number:5004 |
| Z-0035-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Grasping Forceps
Catalog Number: 5008 |
| Z-0036-2023 | Hobbs Medical, Inc. | 2 | Hobbs Retrieval Forceps
Catalog Number: 5018 |
| Z-0037-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number: 6001 |
| Z-0038-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number:6004 |
| Z-0039-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits (containing 6105)
Catalog Number: 6023 |
| Z-0040-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number: 6024 |
| Z-0041-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits (contains 3412)
Catalog Number: 6027 |
| Z-0042-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits (containing 3412)
Catalog Number: 6028 |
| Z-0043-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits
Catalog Number: 6104 |
| Z-0044-2023 | Hobbs Medical, Inc. | 2 | Hobbs Biliary Pigtail Stent Kits
Catalog Number: 6105 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014383302 | YANCHENG HUIDA MEDICAL INSTRUMENTS CO., LTD | Yancheng Jiangsu, CN |
| 3010726901 | EVONOS GMBH & CO. KG | Tuttlingen Baden-Wurttemberg, DE |
| 3017178443 | Guangzhou Aoqun New Materials Co.,Ltd | Guangzhou Guangdong, CN |
| 2023790 | Medical Packaging Corporation | Camarillo, CA, US |
| 1320894 | CONMED CORPORATION | Utica, NY, US |
1220592 when referencing this establishment in official correspondence.