FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSASTAT MULTIPOLAR SCISSORS AND CABLES
K Number: K974250
·
Decision Feb 11, 1998
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
90
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Basic Information
- Device Name
- VERSASTAT MULTIPOLAR SCISSORS AND CABLES
- K Number
- K974250
- 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
- Pilling Weck, Inc.
- Date Received
- November 13, 1997
- Decision Date
- February 11, 1998
- 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 Pilling Weck, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990547 | PILLING WECK SURGICAL Y STENT FORCEPS | Apr 27, 1999 | Substantially Equivalent |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Nov 19, 1996 | Substantially Equivalent |
| K945520 | HEMOCLIP ECOSYSTEM | Jan 27, 1995 | Substantially Equivalent |
| K944552 | PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP | Nov 7, 1994 | Substantially Equivalent |
| K943719 | VISISTAT STAPLER | Aug 24, 1994 | Substantially Equivalent |