FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MILL-ROSE SCOPE CLEANING BRUSH
K Number: K946293
·
Decision Feb 16, 1995
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
3
Applicant Total
46
Review Days
51
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Basic Information
- Device Name
- MILL-ROSE SCOPE CLEANING BRUSH
- K Number
- K946293
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mill-Rose Laboratory
- Date Received
- December 27, 1994
- Decision Date
- February 16, 1995
- Product Code
- MNL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNL | Accessories, Cleaning Brushes, For Endoscope | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Mill-Rose Laboratory
| K Number | Device Name | ||
|---|---|---|---|
| K983122 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT | Oct 30, 1998 | Substantially Equivalent |
| K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | Oct 30, 1998 | Substantially Equivalent |
| K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE | May 23, 1997 | Substantially Equivalent |
| K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | Jul 29, 1996 | Substantially Equivalent |
| K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH | Apr 29, 1996 | Substantially Equivalent |
| K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE | Dec 22, 1995 | Substantially Equivalent |
| K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE | Dec 18, 1995 | Substantially Equivalent |
| K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES | Nov 27, 1995 | Substantially Equivalent |
| K951051 | RITE-BITE BIOPSY FORCEPS | Mar 24, 1995 | Substantially Equivalent |
| K951048 | RITE-BITE BIOPSY FORCEPS | Mar 15, 1995 | Substantially Equivalent |