FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AVITENE DISPENSER SYRINGE
K Number: K924517
·
Decision Oct 27, 1993
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
5
Review Days
418
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Basic Information
- Device Name
- AVITENE DISPENSER SYRINGE
- K Number
- K924517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nusurg, Inc.
- Date Received
- September 4, 1992
- Decision Date
- October 27, 1993
- Product Code
- KYZ
- 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
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Other Clearances by Nusurg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924792 | MULTIPLE PURPOSE FORCEPS | Apr 28, 1994 | Substantially Equivalent |
| K930610 | TALC DISPENSER SYRINGE | Nov 4, 1993 | Substantially Equivalent |
| K924372 | LAPAROSCOPIC NERVE HOOK | Jul 30, 1993 | Substantially Equivalent |
| K924196 | LAPAROSCOPIC NEEDLE HOLDER | Jun 25, 1993 | Substantially Equivalent |