FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
K Number: K983124
·
Decision Oct 30, 1998
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
46
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
- K Number
- K983124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mill-Rose Laboratory
- Date Received
- September 8, 1998
- Decision Date
- October 30, 1998
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOQ), ordered by most recent decision date.
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SmartClip Delivery Catheter (ADR-1715)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FUJIFILM Ultrasonic Endoscope EB-710US
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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 |
| 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 |
| K946293 | MILL-ROSE SCOPE CLEANING BRUSH | Feb 16, 1995 | Substantially Equivalent |