Mill-Rose Laboratory
Medical device manufacturer in Mentor, OH.
46510(k) clearances
0PMA approvals
0recalls
Device types
- EOQ Bronchoscope (Flexible Or Rigid) 11
- GEN Forceps, General & Plastic Surgery 6
- GEI Electrosurgical, Cutting & Coagulation &… 3
- FBK Endoscopic Injection Needle… 3
- FCL Forceps, Biopsy, Non-Electric 2
- FDI Snare, Flexible 2
- KNS Unit, Electrosurgical, Endoscopic (With Or… 1
- ODD Endoscopic Retrograde Cholangiopancreatograp… 1
- BTG Brush, Biopsy, Bronchoscope (Non-Rigid) 1
- FED Endoscopic Access Overtube, Gastroenterology… 1
- FAT Bougie, Esophageal, And Gastrointestinal… 1
- LQR Dislodger, Stone, Biliary 1
- LDZ Fixative, Alcohol Containing 1
- FDF Colonoscope And Accessories, Flexible/Rigid 1
- GAA Needle, Aspiration And Injection, Disposable 1
- FCK Instrument, Biopsy, Suction 1
- GDM Needle, Aspiration And Injection, Reusable 1
- OCZ Endoscopic Grasping/Cutting Instrument… 1
- LRO General Surgery Tray 1
- FFL Dislodger, Stone, Basket, Ureteral, Metal 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K983124 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural KitEOQ · Traditional | 10/30/1998SE |
| K983122 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…EOQ · Traditional | 10/30/1998SE |
| K971275 | Mill-Rose Disposable Polypectomy SnareFDI · Traditional | 05/23/1997SE |
| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
| K960880 | Mill-Rose Blind Microbiology BrushEOQ · Traditional | 04/29/1996SE |
| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | 12/22/1995SE |
| K951600 | Mill-Rose Rotatable Polypectomy SnareFDI · Traditional | 12/18/1995SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | 11/27/1995SE |
| K951051 | Rite-Bite Biopsy ForcepsEOQ · Traditional | 03/24/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
| K950559 | Diener Retrieval DevicesFCL · Traditional | 02/16/1995SE |
| K946293 | Mill-Rose Scope Cleaning BrushMNL · Traditional | 02/16/1995SE |
| K944649 | Mill-Rose Harrell Bronchial BrushEOQ · Traditional | 11/30/1994SE |
| K944650 | Wang Bronchial Needle BrushEOQ · Traditional | 11/22/1994SE |
| K942630 | Wang/Mill-Rose Pleural Biopsy NeedleKNW · Traditional | 07/12/1994SE |
| K921680 | E-Z PegKNT · Traditional | 05/06/1994SEKD |
| K940521 | Mill-Rose Protected Translaryngoscopic CatheterEOQ · Traditional | 05/04/1994SE |
| K935858 | Mill-Rose Percutaneous Procedural KitLRO · Traditional | 02/22/1994SEKD |
| K922204 | Mill-Rose Pulmonary ForcepsEOQ · Traditional | 07/13/1993SE |
| K921800 | Colonoscopic Injection Needle, C-323/C-325FBK · Traditional | 02/08/1993SE |
| K914181 | Wang/Mill-Rose Transbronchial Aspiration NeedleEOQ · Traditional | 12/10/1991SE |
| K910536 | Protected Bronchoalveolar Lavage Balloon CatheterEOQ · Traditional | 09/24/1991SE |
| K901995 | Pleura Biopsy DeviceGDM · Traditional | 07/10/1990SE |
| K895420 | Suction Biopsy InstrumentFCK · Traditional | 02/09/1990SE |
| K894326 | Thoracentisis KitGAA · Traditional | 07/24/1989SE |
| K884857 | Colonoscope Guiding Tube DeviceFDF · Traditional | 03/17/1989SE |
| K862725 | Saccomanno Speciman SolutionLDZ · Traditional | 08/01/1986SE |
| K850489 | Endosopic Stene Manipulating BalloonLQR · Traditional | 04/22/1985SE |
| K842679 | Esophageal Dilator SetFAT · Traditional | 10/02/1984SE |
| K833268 | Endoscopic OvertubeFED · Traditional | 10/31/1983SE |
| K820771 | Microbiology Specimen BrushBTG · Traditional | 05/03/1982SE |
| K820971 | Diathermic Handle for Biopsy ForcepsGEI · Traditional | 04/29/1982SE |
| K820983 | Hot Biopsy Forceps W/Round CupsGEI · Traditional | 04/26/1982SE |
| K820980 | Biopsy Forceps W/Oval Cup & NeedleGEN · Traditional | 04/26/1982SE |
| K820972 | Biopsy Forceps W/Oval CupsGEN · Traditional | 04/26/1982SE |
| K820970 | Retrieval Forceps W/Rattoothed JawsGEN · Traditional | 04/26/1982SE |
| K820969 | Biopsy Forcepw W/Small Oval CupsGEN · Traditional | 04/26/1982SE |
| K820968 | Retrieval Forceps W/Alligator JawsGEN · Traditional | 04/26/1982SE |
| K820967 | Biopsy Forceps W/Alligator Type CupsGEN · Traditional | 04/26/1982SE |
| K820973 | Endoscopic Injection NeedleFBK · Traditional | 04/16/1982SE |
| K802444 | Papillotome ProductKNS · Traditional | 10/23/1980SE |
| K802443 | E.R.C.P. Cannula ProductODD · Traditional | 10/23/1980SE |
| K792345 | Retrievable ForcepsOCZ · Traditional | 12/20/1979SE |
| K792344 | Stone and Retrieval BasketFFL · Traditional | 12/20/1979SE |
| K792343 | Diathermic Snare (Cresent Type)GEI · Traditional | 12/18/1979SE |
| K791668 | Endoscopic Cytology BrushesFDX · Traditional | 10/01/1979SE |