FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIPOLAR SUCTION ELECTRODE
K Number: K843498
·
Decision Dec 14, 1984
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
22
Applicant Total
10
Review Days
99
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
- BIPOLAR SUCTION ELECTRODE
- K Number
- K843498
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Eder Instrument Co, Inc.
- Date Received
- September 6, 1984
- Decision Date
- December 14, 1984
- Product Code
- GET
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GET), ordered by most recent decision date.
AESCULAP POWER SYSTEM HANDPIECE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NUCLEOTOME L KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MIDAS REX TELESCOPING SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Eder Instrument Co, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843497 | SURGICAL KNIVES & PROBES | Oct 31, 1984 | Substantially Equivalent |
| K843499 | ARTHROSCOPY LEG HOLDER | Oct 31, 1984 | Substantially Equivalent |
| K831255 | LARYNGOSCOPE ATTACHMENT PH2000 | Sep 12, 1983 | Substantially Equivalent |
| K831240 | LASER BRONCHOSCOPE | Jul 26, 1983 | Substantially Equivalent |
| K831241 | LASER LAPARAXOPE | Jun 10, 1983 | Substantially Equivalent |
| K822959 | ENDOSCOPIC VIDEOSYSTEM | Oct 22, 1982 | Substantially Equivalent |
| K802479 | SURGICAL KNIVES & PROBES | Oct 31, 1980 | Substantially Equivalent |
| K792100 | GRASPING FORCEP (W/FOUR PRONGS) | Nov 13, 1979 | Substantially Equivalent |
| K791052 | ENDOSCOPIC INSTRUMENT | Aug 3, 1979 | Substantially Equivalent |