FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
K Number: K972109
·
Decision Nov 14, 1997
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
7
Applicant Total
14
Review Days
162
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Basic Information
- Device Name
- SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
- K Number
- K972109
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Surgical Innovations
- Date Received
- June 5, 1997
- Decision Date
- November 14, 1997
- 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
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Other Clearances by General Surgical Innovations
| K Number | Device Name | ||
|---|---|---|---|
| K983318 | FIXATION SYSTEM | Mar 1, 1999 | Substantially Equivalent |
| K973046 | SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK | Jan 16, 1998 | Substantially Equivalent |
| K970201 | GSI CANNULA WITH INTRODUCER | Apr 21, 1997 | Substantially Equivalent |
| K962702 | SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA | Feb 19, 1997 | Substantially Equivalent |
| K961356 | MAMMARY SIZER | Sep 23, 1996 | Substantially Equivalent for Some Indications |
| K952278 | THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA | Aug 7, 1995 | Substantially Equivalent |
| K951878 | SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA | Jun 29, 1995 | Substantially Equivalent |
| K944418 | THE SPACEMAKER AND THE SPACEMAKER II | Nov 1, 1994 | Substantially Equivalent |
| K944536 | GSI KNOTMAKER | Oct 5, 1994 | Substantially Equivalent |
| K943671 | GSI CANNULA REDUCER ACCESSORY | Aug 9, 1994 | Substantially Equivalent |