FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NINJA SCALPEL
K Number: K873493
·
Decision Sep 24, 1987
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
14
Review Days
24
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Basic Information
- Device Name
- NINJA SCALPEL
- K Number
- K873493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Primrose Medical, Inc.
- Date Received
- August 31, 1987
- Decision Date
- September 24, 1987
- Product Code
- GES
- 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 |
|---|---|---|---|
| GES | Blade, Scalpel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GES), ordered by most recent decision date.
PERSONNA PLUS SAFETY SCALPEL SYSTEM
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EASY-ON
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SCALPEL BLADE REMOVER (BLADEGARD)
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PRECISION GLIDE - ENHANCED SURGICAL BLADE
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STERILE CARBON STEEL SURGICAL BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Primrose Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884714 | BILIARY DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884715 | ACHELASIA BALLOON DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884713 | COLONIC BALLOON DIALATORS | Sep 29, 1989 | Substantially Equivalent |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Sep 29, 1989 | Substantially Equivalent |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Sep 8, 1989 | Substantially Equivalent |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | Sep 8, 1989 | Substantially Equivalent |
| K883420 | LANCET, BLOOD | Aug 26, 1988 | Substantially Equivalent |
| K881976 | CATHETER, INTRAVASCULAR | Aug 4, 1988 | Substantially Equivalent |
| K881977 | PRESSURE INFUSOR | Jul 29, 1988 | Substantially Equivalent |
| K881975 | SET, INTRAVASCULAR | Jul 29, 1988 | Substantially Equivalent |