FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
K Number: K981458
·
Decision May 20, 1998
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
35
Review Days
27
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
- KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
- K Number
- K981458
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoscopy
- Date Received
- April 23, 1998
- Decision Date
- May 20, 1998
- Product Code
- EOB
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOB), ordered by most recent decision date.
Hydro Irrigation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ENTity USB Videoscope System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Outlook Surgical Versa One System (8900139)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Portare System (FA-001)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Karl Storz Endoscopy
| K Number | Device Name | ||
|---|---|---|---|
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | Jan 24, 2005 | Substantially Equivalent |
| K030848 | PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Jun 2, 2003 | Substantially Equivalent |
| K030009 | KSEA POWERSHAVER SYSTEM S2 | Apr 2, 2003 | Substantially Equivalent |
| K023924 | AUTOCON II 200 ELECTROSURGICAL GENERATOR | Feb 21, 2003 | Substantially Equivalent |
| K023187 | KSEA SPINOSCOPE | Dec 2, 2002 | Substantially Equivalent |
| K011700 | MODULITH SLK LITHOTRIPTER | Aug 16, 2002 | Substantially Equivalent |
| K021776 | KSEA QUADRO SWITCH | Aug 15, 2002 | Substantially Equivalent |
| K013107 | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Feb 26, 2002 | Substantially Equivalent |
| K011841 | KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR | Sep 10, 2001 | Substantially Equivalent |
| K010569 | KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP | Apr 9, 2001 | Substantially Equivalent |