FDA Device Registration & Listing · KNITTLINGEN Baden-Wurttemberg, DE · Registration 9611102
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 1994-05-09 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 1998-02-20 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1998-03-24 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 1998-02-20 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2000-05-17 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2016-09-19 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-05-06 |
| FGA | Kit, Nephroscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-05-06 |
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-05-06 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-20 |
| FWC | Camera, Television, Surgical, With Audio | General, Plastic Surgery | Class 1 | 878.4160 | 2016-09-20 |
| FWG | Camera, Television, Endoscopic, With Audio | General, Plastic Surgery | Class 1 | 878.4160 | 2016-09-20 |
| MNK | Endoscopic Bite Block | Gastroenterology, Urology | Class 1 | 876.1500 | 1998-03-11 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Obstetrics/Gynecology | Class 1 | 884.1730 | 2014-10-31 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| GCT | Light Source, Endoscope, Xenon Arc | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-03-01 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-07-13 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2016-09-20 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-09-19 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-19 |
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-10-22 |
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-10-22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-19 |
| GWG | Endoscope, Neurological | Neurology | Class 2 | 882.1480 | 2016-09-19 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2022-12-15 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2022-01-18 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2010-04-08 |
| FJL | Resectoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-04-08 |
| KQT | Evacuator, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.4370 | 2010-04-08 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2000-04-24 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 1998-03-12 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 1986-05-09 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| FCY | Bulb, Inflation, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 1978-03-31 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2016-09-19 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1998-02-20 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 1998-03-12 |
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-03-31 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-06-29 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2018-09-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-05-11 |
| GCM | Endoscope, Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-05-11 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 1998-02-04 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | Ear, Nose, Throat | Class 2 | 874.4500 | 2016-09-19 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Anesthesiology | Class 1 | 868.5640 | 1978-03-31 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-19 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-09-05 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| GWG | Endoscope, Neurological | Neurology | Class 2 | 882.1480 | 2016-09-19 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-19 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 1998-02-20 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 1997-08-26 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Gastroenterology, Urology | Class 1 | 876.1500 | 1978-03-31 |
| EQL | Laryngostroboscope | Ear, Nose, Throat | Class 1 | 874.4750 | 1999-03-31 |
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | Class 1 | 874.4350 | 2011-07-26 |
| GCM | Endoscope, Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| FBP | Telescope, Rigid, Endoscopic | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2023-05-22 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2014-09-08 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2010-03-30 |
| GCM | Endoscope, Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-03-30 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2010-03-30 |
| FJL | Resectoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-03-30 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 1986-05-09 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | Class 2 | 876.4680 | 2013-10-28 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2013-10-28 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2013-10-28 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| FJL | Resectoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-11-18 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | Class 2 | 878.4780 | 2009-11-18 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4820 | 2009-11-18 |
| SCV | Modular Electromechanical Surgical System | General, Plastic Surgery | Class 2 | 878.4964 | 2026-01-13 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| HDP | Elevator, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2011-07-29 |
| HEW | Culdoscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1640 | 2011-07-29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-19 |
| FBQ | Trocar, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.5090 | 2016-09-20 |
| HHI | System, Abortion, Vacuum | Obstetrics/Gynecology | Class 2 | 884.5070 | 2016-05-25 |
| ODA | Endoscopic Central Control Unit | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-19 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| ISN | Cable | Physical Medicine | Class 1 | 890.3420 | 1997-10-01 |
| CAM | Yoke Assembly, Medical Gas | Anesthesiology | Class 1 | 868.6885 | 1997-10-01 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| GCT | Light Source, Endoscope, Xenon Arc | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-03-01 |
| FCT | Headlight, Fiberoptic Focusing | Ophthalmic | Class 2 | 886.4335 | 2018-09-24 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 1998-03-24 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-01-17 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | Class 2 | 876.4680 | 1998-03-11 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-20 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2001-08-24 |
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | Class 2 | 884.1700 | 2016-09-20 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2016-09-20 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2010-08-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-16 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-09-20 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-09-20 |
| FCZ | Tube, Smoke Removal, Endoscopic | Gastroenterology, Urology | Class 1 | 876.1500 | 1997-10-01 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2016-09-20 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2016-09-20 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2010-03-10 |
| GWG | Endoscope, Neurological | Neurology | Class 2 | 882.1480 | 2016-09-20 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2013-10-28 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-08-29 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2022-07-12 |
| FXQ | Lens, Camera, Surgical | General, Plastic Surgery | Class 1 | 878.4160 | 2013-04-05 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 1998-10-15 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2015-12-28 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2016-09-19 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2016-09-19 |
| HHR | Laser, Surgical, Gynecologic | Obstetrics/Gynecology | Class 2 | 884.4550 | 2016-09-19 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-20 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2016-08-23 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2016-08-23 |
| FJL | Resectoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-08-23 |
| FDC | Resectoscope, Working Element | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-08-23 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2016-09-20 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 1998-02-20 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2016-09-19 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2010-03-30 |
| OTJ | Laparoscopic Single Port Access Device | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-08-09 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2014-09-15 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2001-02-22 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | Class 2 | 876.4680 | 2010-03-10 |
| FEC | Obturator, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-03-10 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-03-10 |
| FGA | Kit, Nephroscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-03-10 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-09-20 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2016-09-16 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-20 |
| ISA | Massager, Therapeutic, Electric | Physical Medicine | Class 1 | 890.5660 | 2009-06-18 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-09-20 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2022-06-28 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2022-06-28 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2021-05-17 |
| GCM | Endoscope, Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-05-17 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-05-17 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 1998-03-24 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| GAE | Snare, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1998-03-11 |
| FBO | Cystourethroscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-04-30 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| PHT | Basin For Endoscope Reprocessing | Gastroenterology, Urology | Class 1 | 876.1500 | 2023-09-27 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-11-18 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2009-11-18 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2015-12-28 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 1998-03-24 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 1997-10-01 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-03-30 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2016-06-29 |
| FGA | Kit, Nephroscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-19 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2004-10-04 |
| FWF | Camera, Television, Endoscopic, Without Audio | General, Plastic Surgery | Class 1 | 878.4160 | 1998-03-12 |
| FDE | Laparoscopy Kit | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2016-09-20 |
| DRI | Monitor, Line Isolation | Cardiovascular | Class 1 | 870.2620 | 2016-01-11 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2013-04-05 |
| EXY | Uroflowmeter | Gastroenterology, Urology | Class 2 | 876.1800 | 1978-03-31 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4150 | 2016-09-20 |
| FHR | Needle, Gastro-Urology | General, Plastic Surgery | Class 1 | 878.4800 | 2024-03-11 |
| KAA | Set, Laryngeal Injection | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-02-25 |
| FXM | Camera, Still, Endoscopic | General, Plastic Surgery | Class 1 | 878.4160 | 2011-12-30 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2016-09-20 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-09-20 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-04-05 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-24 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-24 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-09-20 |
| EWY | Mediastinoscope, Surgical | Ear, Nose, Throat | Class 2 | 874.4720 | 2011-06-14 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2010-03-30 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2010-03-30 |
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | Class 1 | 884.1720 | 2024-03-11 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2001-08-24 |
| ODA | Endoscopic Central Control Unit | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-19 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 1998-03-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-09-20 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1418479 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | VERNON HILLS, IL, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K936071 | Smith & Nephew Dyonics, Inc. | SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE | 1994-08-19 |
| K953574 | American Hydro-Surgical Instruments, Inc. | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER | 1995-09-29 |
| K915458 | Psi Medical Products, Inc. | URETEROSCOPE | 1992-01-30 |
| K914997 | Conmedcorp | ASP-IRRATOR | 1992-01-07 |
| K153773 | Olympus Medical Systems Corp. | Disposal Lens Cleaning Sheath | 2016-11-22 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0007-2013 | Invuity, Inc. | 2 | BriteField illuminated Suction Device;
Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray.
The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. |
| Z-0023-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures. |
| Z-0024-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures. |
| Z-0025-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures. |
| Z-0026-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8040278 | Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, PK |
| 9614986 | OTTO LEIBINGER GMBH | MUEHLHEIM Baden-Wurttemberg, DE |
| 3008338766 | CROWN SURGICAL CORP. | Sialkot Punjab, PK |
| 3010041511 | Teleflex LLC (NADC) | Olive Branch, MS, US |
| 3032747418 | HEXAMED PVT LTD | Sialkot Punjab, PK |
9611102 when referencing this establishment in official correspondence.