FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIRCOLL BALLOON DISSECTOR
K Number: K984448
·
Decision Jan 28, 1999
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
7
Applicant Total
15
Review Days
45
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Basic Information
- Device Name
- BIRCOLL BALLOON DISSECTOR
- K Number
- K984448
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wells Johnson Co.
- Date Received
- December 14, 1998
- Decision Date
- January 28, 1999
- Product Code
- FZW
- 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 |
|---|---|---|---|
| FZW | Expander, Surgical, Skin Graft | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZW), ordered by most recent decision date.
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
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SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
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AESCULAP SKIN GRAFT MESHER
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INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
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SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Wells Johnson Co.
| K Number | Device Name | ||
|---|---|---|---|
| K991437 | WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 | Aug 30, 1999 | Substantially Equivalent |
| K971580 | UAS ULTRASONIC ASPIRATOR SYSTEM | Dec 9, 1997 | Substantially Equivalent |
| K945876 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Dec 4, 1995 | Substantially Equivalent |
| K945500 | WELLS JOHNSON FIXATION SYSTEM | Sep 21, 1995 | Substantially Equivalent |
| K951519 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Jun 14, 1995 | Substantially Equivalent |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Mar 2, 1995 | Substantially Equivalent |
| K945805 | WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE | Dec 13, 1994 | Substantially Equivalent |
| K854068 | EXTERNAL MECHANICAL FASTENER | Nov 22, 1985 | Substantially Equivalent |
| K843188 | WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP | Sep 20, 1984 | Substantially Equivalent |
| K832520 | SUCTION TIPS | Oct 20, 1983 | Substantially Equivalent |