FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
K Number: K921886
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
35
Applicant Total
1
Review Days
167
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
- NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
- K Number
- K921886
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Needle Technologies, Inc.
- Date Received
- April 21, 1992
- Decision Date
- October 5, 1992
- Product Code
- IWJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IWJ | System, Applicator, Radionuclide, Manual | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWJ), ordered by most recent decision date.
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
PGK DEVICE (MODIFIED)
FDA 510(k)
FDA Class 1
·Radiology
REGANES RADIONUCLIDE SEED MAGAZINE
FDA 510(k)
FDA Class 1
·Radiology
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
FDA 510(k)
FDA Class 1
·Radiology
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
FDA 510(k)
FDA Class 1
·Radiology
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
FDA 510(k)
FDA Class 1
·Radiology