FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRODES
K Number: K944992
·
Decision Apr 27, 1995
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
93
Review Days
197
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
- ELECTRODES
- K Number
- K944992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Linvatec Corp.
- Date Received
- October 12, 1994
- Decision Date
- April 27, 1995
- Product Code
- JOS
- 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 |
|---|---|---|---|
| JOS | Electrode, Electrosurgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOS), ordered by most recent decision date.
Resection Electrodes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REPROCESSED ELECTROSURGICAL ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDLINE GROUNDING PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Linvatec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | Dec 23, 2009 | Substantially Equivalent |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | Jun 23, 2009 | Substantially Equivalent |
| K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR | Jun 22, 2009 | Substantially Equivalent |
| K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES | Apr 10, 2009 | Substantially Equivalent |
| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | Feb 25, 2009 | Substantially Equivalent |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | May 11, 2006 | Substantially Equivalent |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Apr 10, 2006 | Substantially Equivalent |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | Apr 10, 2006 | Substantially Equivalent |
| K050519 | ADVANCED TURBO DRIVE SYSTEM | May 17, 2005 | Substantially Equivalent |
| K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | Mar 25, 2005 | Substantially Equivalent |