FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000
K Number: K950495
·
Decision May 9, 1995
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
12
Review Days
92
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Basic Information
- Device Name
- SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000
- K Number
- K950495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Dynamics, Inc.
- Date Received
- February 6, 1995
- Decision Date
- May 9, 1995
- Product Code
- BTA
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Surgical Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960046 | SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE | Apr 2, 1996 | Substantially Equivalent |
| K942987 | NUCLEOTOME L KIT | Oct 30, 1995 | Substantially Equivalent |
| K954193 | SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET | Oct 23, 1995 | Substantially Equivalent |
| K931109 | NUCLEOTOME E KIT | Mar 29, 1994 | Substantially Equivalent for Some Indications |
| K921950 | SURGICAL DYNAMICS DISCOGRAPHY SYSTEM | Jun 7, 1993 | Unknown |
| K923525 | NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR | Feb 9, 1993 | Substantially Equivalent |
| K913145 | NUCLEOTOME TISSUE ASPIRATOR/CUTTER | Dec 19, 1991 | Substantially Equivalent |
| K914282 | NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER | Dec 19, 1991 | Substantially Equivalent |
| K902778 | SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER | Oct 30, 1990 | Substantially Equivalent |
| K894336 | SURGICAL DYNAMICS DISCOGRAPHY SYSTEM | Aug 4, 1989 | Unknown |