FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENSTAT
K Number: K010465
·
Decision May 14, 2001
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
26
Review Days
87
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Basic Information
- Device Name
- DENSTAT
- K Number
- K010465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Elmed, Inc.
- Date Received
- February 16, 2001
- Decision Date
- May 14, 2001
- 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 Elmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974793 | ELMED ESU 120 M/M DIGITAL | Mar 19, 1998 | Substantially Equivalent |
| K953271 | ELMED RF-ALERT | Jan 18, 1996 | Substantially Equivalent |
| K952110 | ELMED THERMO-FLUX | Aug 14, 1995 | Substantially Equivalent |
| K926517 | ELMED LBC 50-P | Nov 15, 1994 | Substantially Equivalent |
| K932938 | ELMED ESU 300 M/M AND DIGITAL | May 2, 1994 | Substantially Equivalent |
| K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | May 17, 1993 | Substantially Equivalent |
| K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL | Nov 5, 1992 | Substantially Equivalent |
| K905417 | ELMED PNEUMOMAT DIGITAL | Jan 31, 1991 | Substantially Equivalent |
| K881431 | SIEMENS STEREODYNATOR 828 | Apr 16, 1990 | Substantially Equivalent |
| K875238 | SIEMENS NEUROTON 826 AND 827 | Mar 10, 1988 | Substantially Equivalent |