FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES
K Number: K936246
·
Decision Jul 21, 1994
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
203
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Basic Information
- Device Name
- MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES
- K Number
- K936246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicon Instruments, Inc.
- Date Received
- December 30, 1993
- Decision Date
- July 21, 1994
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medicon Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K936249 | MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES | Jul 21, 1994 | Substantially Equivalent |
| K936262 | DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS | Jul 1, 1994 | Substantially Equivalent |
| K936247 | MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | May 19, 1994 | Substantially Equivalent |
| K936248 | MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS | May 16, 1994 | Substantially Equivalent |
| K936250 | RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP | May 12, 1994 | Substantially Equivalent |