FDA Device Registration & Listing · Norwalk, OH, US · Registration 1519132
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2021-02-22 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2021-02-22 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| HEW | Culdoscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1640 | 2021-02-22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2021-02-22 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2021-02-22 |
| OCU | Endoscopic Storage Cover | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2021-02-22 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2021-02-22 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2021-02-22 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2021-02-22 |
| FEO | Lithotriptor, Ultrasonic | Gastroenterology, Urology | Class 2 | 876.4480 | 2021-02-22 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-22 |
| FGO | Dislodger, Stone, Flexible | Gastroenterology, Urology | Class 2 | 876.4680 | 2021-02-22 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2021-02-22 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2021-02-22 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2021-02-22 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2021-02-22 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2021-02-22 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| KOB | Catheter, Suprapubic (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5090 | 2021-02-22 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-02-22 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2021-02-22 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3008933393 | Nissha Medical Technologies Limited | Paignton Devon, GB |
| 1317188 | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | BUFFALO, NY, US |
| 3006891611 | CEA Global Dominicana d.b.a. Nissha Medical Technologies | San Pedro de Macoris, DO |
| 3023164 | LEAD-LOK, INC. d.b.a Nissha Medical Technologies | Sandpoint, ID, US |
| 1721983 | CEA Medical Manufacturing, Inc. | Colorado Springs, CO, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K885255 | Candela Laser Corp. | MDL-1 LASERTRIPTER(TM) | 1989-06-01 |
| K914997 | Conmedcorp | ASP-IRRATOR | 1992-01-07 |
| K153773 | Olympus Medical Systems Corp. | Disposal Lens Cleaning Sheath | 2016-11-22 |
| K940141 | Micro-Medical Devices, Inc. | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | 1994-05-19 |
| K933812 | Advanced Surgical, Inc. | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | 1993-12-13 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0144-2024 | Covidien | 1 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
| Z-0168-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only |
| Z-0169-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only |
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3026201231 | IntuBlade Co. | Lisle, IL, US |
| 3019784580 | AIMD INC. | Seoul, KR |
| 3004530184 | ANDERSEN CALEDONIA LTD | Bellshill Scotland, GB |
| 1824226 | KING SYSTEMS CORPORATION. | Noblesville, IN, US |
| 9681384 | Covidien | Ciudad Juarez Chihuahua, MX |
1519132 when referencing this establishment in official correspondence.