FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR
K Number: K944012
·
Decision Dec 21, 1994
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
55
Review Days
127
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Basic Information
- Device Name
- ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR
- K Number
- K944012
- 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
- Aspen Laboratories, Inc.
- Date Received
- August 16, 1994
- Decision Date
- December 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 Aspen Laboratories, Inc.
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|---|---|---|---|
| K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT | Apr 21, 1998 | Substantially Equivalent |
| K963088 | SHEATH, ELECTROSURGICAL PENCIL | Sep 13, 1996 | Substantially Equivalent |
| K955834 | SYSTEM 6500 ABC ELECTROSURGICAL UNIT | Jul 11, 1996 | Substantially Equivalent |
| K960296 | 4000 ETM | Feb 20, 1996 | Substantially Equivalent |
| K953081 | BEAMER PLUS | Oct 30, 1995 | Substantially Equivalent |
| K953007 | EXCALIBUR PLUS ELECTROSURGICAL UNIT | Aug 21, 1995 | Substantially Equivalent |
| K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL | Apr 3, 1995 | Substantially Equivalent |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | Apr 16, 1993 | Substantially Equivalent |
| K913213 | SINGLE USE LEE ELECTRODE | Feb 13, 1992 | Substantially Equivalent |
| K896838 | BISTAT ELECTROSURGICAL UNIT 60-5400-001 | Feb 13, 1990 | Substantially Equivalent |