FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAG SPIGOT
K Number: K910673
·
Decision Apr 24, 1991
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
16
Review Days
68
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Basic Information
- Device Name
- BAG SPIGOT
- K Number
- K910673
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Procedure Products, Inc.
- Date Received
- February 15, 1991
- Decision Date
- April 24, 1991
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Procedure Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161812 | Freedom Syringe | Mar 27, 2017 | Substantially Equivalent |
| K923194 | INSUFFLATOR CONNECTING FILTER | Oct 8, 1993 | Substantially Equivalent |
| K922536 | TORQUE DEVICE | Dec 10, 1992 | Substantially Equivalent |
| K914128 | CONNECTING SET | Nov 27, 1991 | Substantially Equivalent |
| K884985 | MODIFIED 10CC SYRINGE CONTROL RING SET | Dec 20, 1988 | Substantially Equivalent |
| K874747 | 10CC SYRINGE CONTROL RING SET | Feb 4, 1988 | Substantially Equivalent |
| K874037 | ANGIO WASTE FLUIDS DUMP BAG | Jan 29, 1988 | Substantially Equivalent |
| K853749 | CUSTOM CORONARY MANIFOLD KITS | Jan 13, 1986 | Substantially Equivalent |
| K842173 | DISPOSABLE STOPCOCKS | Sep 5, 1984 | Substantially Equivalent |
| K833554 | MATERIAL ADDITION LEXAN & K-RESIN | Mar 12, 1984 | Substantially Equivalent |