FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
K Number: K962935
·
Decision Sep 3, 1996
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
13
Review Days
36
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Basic Information
- Device Name
- UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
- K Number
- K962935
- 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
- Unimed Surgical Products, Inc.
- Date Received
- July 29, 1996
- Decision Date
- September 3, 1996
- 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 Unimed Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES | Oct 8, 2013 | Substantially Equivalent |
| K993647 | UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F | Nov 16, 1999 | Substantially Equivalent |
| K970066 | UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE | Feb 18, 1997 | Substantially Equivalent |
| K963338 | UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH | Oct 21, 1996 | Substantially Equivalent |
| K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE | Jul 25, 1995 | Substantially Equivalent |
| K944265 | NEEDLE ELCTRODE | May 5, 1995 | Substantially Equivalent |
| K946246 | SURGI-LINK BIPOLAR MICRO FORCEPS | Mar 7, 1995 | Substantially Equivalent |
| K945030 | SURGI-LINK LAPAROSCOPIC ELECTRODES | Nov 3, 1994 | Substantially Equivalent |
| K944898 | SURGI-LINK BIPOLAR ELECTRODES | Nov 1, 1994 | Substantially Equivalent |
| K944617 | SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL | Sep 29, 1994 | Substantially Equivalent |