FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
K Number: K993306
·
Decision Nov 3, 1999
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
30
Applicant Total
14
Review Days
30
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Basic Information
- Device Name
- NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
- K Number
- K993306
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paladin Medical, Inc.
- Date Received
- October 4, 1999
- Decision Date
- November 3, 1999
- Product Code
- HAM
- 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 |
|---|---|---|---|
| HAM | Apparatus, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Paladin Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970347 | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM | Aug 29, 1997 | Substantially Equivalent |
| K971290 | STRATASYS FDM MEDMODELER SYSTEM | Jun 20, 1997 | Substantially Equivalent |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Dec 20, 1996 | Substantially Equivalent |
| K950054 | ENDO-BEND(TM) SHAVER | Jun 29, 1995 | Substantially Equivalent |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Nov 29, 1993 | Substantially Equivalent |
| K921015 | SHARPE ENDOSPONGE ASPIIRATOR | May 21, 1993 | Substantially Equivalent |
| K915743 | SHARPE ENDOTENACULUM | May 20, 1993 | Substantially Equivalent |
| K921888 | SHARPE ENDODISSECTOR | Oct 20, 1992 | Substantially Equivalent |
| K915747 | SHARPE ENDOFORCEPS | Oct 20, 1992 | Substantially Equivalent |
| K915744 | SHARPE ENDOHEMOSTAT | Oct 20, 1992 | Substantially Equivalent |