FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE LEE ELECTRODE
K Number: K913213
·
Decision Feb 13, 1992
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
52
Applicant Total
55
Review Days
209
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Basic Information
- Device Name
- SINGLE USE LEE ELECTRODE
- K Number
- K913213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aspen Laboratories, Inc.
- Date Received
- July 19, 1991
- Decision Date
- February 13, 1992
- Product Code
- HGI
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Aspen Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR | Dec 21, 1994 | Substantially Equivalent |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | Apr 16, 1993 | Substantially Equivalent |
| K896838 | BISTAT ELECTROSURGICAL UNIT 60-5400-001 | Feb 13, 1990 | Substantially Equivalent |