FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SESQUIPOLAR(TM) MIS ELECTRODE
K Number: K922289
·
Decision Jan 15, 1993
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
18
Review Days
245
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Basic Information
- Device Name
- SESQUIPOLAR(TM) MIS ELECTRODE
- K Number
- K922289
- 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
- Beacon Laboratories, Inc.
- Date Received
- May 15, 1992
- Decision Date
- January 15, 1993
- 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 Beacon Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930243 | FLEXIBLE EXTENDER | Mar 11, 1994 | Substantially Equivalent |
| K930497 | ARGON HANDPIECES | Jun 25, 1993 | Substantially Equivalent |
| K925708 | DISPOSABLE ELECTROSURGERY BALL ELECTRODE | Apr 20, 1993 | Substantially Equivalent |
| K925619 | DISPOSABLE HAND-SWITCHING ESU PENCIL | Dec 24, 1992 | Substantially Equivalent |
| K915788 | MIS ELECTROSURGICAL ELECTRODES | Mar 13, 1992 | Substantially Equivalent |
| K920100 | GSU HANDPIECE ADAPTER | Feb 3, 1992 | Substantially Equivalent |
| K913772 | PRESSURE GUARD | Nov 19, 1991 | Substantially Equivalent |
| K905752 | ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE | Jul 22, 1991 | Substantially Equivalent |
| K904506 | ACTIVE ADAPTER | Dec 13, 1990 | Substantially Equivalent |
| K902996 | ARGON BEAM LAPAROSCOPIC ELECTRODE | Nov 21, 1990 | Substantially Equivalent |