FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
K Number: K921950
·
Decision Jun 7, 1993
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
12
Review Days
406
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Basic Information
- Device Name
- SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
- K Number
- K921950
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Surgical Dynamics, Inc.
- Date Received
- April 27, 1992
- Decision Date
- June 7, 1993
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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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 |
| K950495 | SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 | May 9, 1995 | Substantially Equivalent |
| K931109 | NUCLEOTOME E KIT | Mar 29, 1994 | Substantially Equivalent for Some Indications |
| 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 |