Mill-Rose Laboratory
Mchenry, IL, US
Mill-Rose Laboratory appears in FDA device records in Mchenry, IL. FDA records list 46 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 46
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 46 510(k) clearances for Mill-Rose Laboratory between 1979 and 1998. The busiest year on record is 1982, with 10. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 4 |
| 1980 | 2 |
| 1982 | 10 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 2 |
| 1993 | 2 |
| 1994 | 6 |
| 1995 | 7 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | EOQ | Substantially Equivalent | |
| K983122 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT | EOQ | Substantially Equivalent | |
| K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE | FDI | Substantially Equivalent | |
| K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | EOQ | Substantially Equivalent | |
| K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH | EOQ | Substantially Equivalent | |
| K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE | FBK | Substantially Equivalent | |
| K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE | FDI | Substantially Equivalent | |
| K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES | FEB | Substantially Equivalent | |
| K951051 | RITE-BITE BIOPSY FORCEPS | EOQ | Substantially Equivalent | |
| K951048 | RITE-BITE BIOPSY FORCEPS | FCL | Substantially Equivalent | |
| K950559 | DIENER RETRIEVAL DEVICES | FCL | Substantially Equivalent | |
| K946293 | MILL-ROSE SCOPE CLEANING BRUSH | MNL | Substantially Equivalent | |
| K944649 | MILL-ROSE HARRELL BRONCHIAL BRUSH | EOQ | Substantially Equivalent | |
| K944650 | WANG BRONCHIAL NEEDLE BRUSH | EOQ | Substantially Equivalent | |
| K942630 | WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K921680 | E-Z PEG | KNT | Unknown | |
| K940521 | MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER | EOQ | Substantially Equivalent | |
| K935858 | MILL-ROSE PERCUTANEOUS PROCEDURAL KIT | LRO | Unknown | |
| K922204 | MILL-ROSE PULMONARY FORCEPS | EOQ | Substantially Equivalent | |
| K921800 | COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 | FBK | Substantially Equivalent | |
| K914181 | WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE | EOQ | Substantially Equivalent | |
| K910536 | PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER | EOQ | Substantially Equivalent | |
| K901995 | PLEURA BIOPSY DEVICE | GDM | Substantially Equivalent | |
| K895420 | SUCTION BIOPSY INSTRUMENT | FCK | Substantially Equivalent | |
| K894326 | THORACENTISIS KIT | GAA | Substantially Equivalent | |
| K884857 | COLONOSCOPE GUIDING TUBE DEVICE | FDF | Substantially Equivalent | |
| K862725 | SACCOMANNO SPECIMAN SOLUTION | LDZ | Substantially Equivalent | |
| K850489 | ENDOSOPIC STENE MANIPULATING BALLOON | LQR | Substantially Equivalent | |
| K842679 | ESOPHAGEAL DILATOR SET | FAT | Substantially Equivalent | |
| K833268 | ENDOSCOPIC OVERTUBE | FED | Substantially Equivalent | |
| K820771 | MICROBIOLOGY SPECIMEN BRUSH | BTG | Substantially Equivalent | |
| K820971 | DIATHERMIC HANDLE FOR BIOPSY FORCEPS | GEI | Substantially Equivalent | |
| K820983 | HOT BIOPSY FORCEPS W/ROUND CUPS | GEI | Substantially Equivalent | |
| K820980 | BIOPSY FORCEPS W/OVAL CUP & NEEDLE | GEN | Substantially Equivalent | |
| K820972 | BIOPSY FORCEPS W/OVAL CUPS | GEN | Substantially Equivalent | |
| K820970 | RETRIEVAL FORCEPS W/RATTOOTHED JAWS | GEN | Substantially Equivalent | |
| K820969 | BIOPSY FORCEPW W/SMALL OVAL CUPS | GEN | Substantially Equivalent | |
| K820968 | RETRIEVAL FORCEPS W/ALLIGATOR JAWS | GEN | Substantially Equivalent | |
| K820967 | BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS | GEN | Substantially Equivalent | |
| K820973 | ENDOSCOPIC INJECTION NEEDLE | FBK | Substantially Equivalent | |
| K802444 | PAPILLOTOME PRODUCT | KNS | Substantially Equivalent | |
| K802443 | E.R.C.P. CANNULA PRODUCT | ODD | Substantially Equivalent | |
| K792345 | RETRIEVABLE FORCEPS | OCZ | Substantially Equivalent | |
| K792344 | STONE AND RETRIEVAL BASKET | FFL | Substantially Equivalent | |
| K792343 | DIATHERMIC SNARE (CRESENT TYPE) | GEI | Substantially Equivalent | |
| K791668 | ENDOSCOPIC CYTOLOGY BRUSHES | FDX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FEBAccessories, Cleaning, For Endoscope
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology
- EOQBronchoscope (Flexible Or Rigid)
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- FDFColonoscope And Accessories, Flexible/Rigid
- FFLDislodger, Stone, Basket, Ureteral, Metal
- LQRDislodger, Stone, Biliary
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- LDZFixative, Alcohol Containing
- FCLForceps, Biopsy, Non-Electric
- GENForceps, General & Plastic Surgery
- LROGeneral Surgery Tray
- KNWInstrument, Biopsy
- FCKInstrument, Biopsy, Suction
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- FDISnare, Flexible
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
