FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NAVARRE 600 ML DRAINAGE BAG
K Number: K943663
·
Decision Sep 8, 1994
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
8
Applicant Total
9
Review Days
42
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Basic Information
- Device Name
- NAVARRE 600 ML DRAINAGE BAG
- K Number
- K943663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Navarre Biomedical , Ltd.
- Date Received
- July 28, 1994
- Decision Date
- September 8, 1994
- Product Code
- EXF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EXF | Bag, Bile Collecting | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXF), ordered by most recent decision date.
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Other Clearances by Navarre Biomedical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K955110 | NAVARRE PERCUTANEOUS BILIARY DRAINAGE | Nov 7, 1996 | Substantially Equivalent |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Feb 7, 1996 | Substantially Equivalent |
| K945909 | NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER | Jun 2, 1995 | Substantially Equivalent |
| K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | May 15, 1995 | Substantially Equivalent |
| K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | Apr 24, 1995 | Substantially Equivalent |
| K942315 | NAVARRE PERCUTANEOUS ACCESS SET | Jul 8, 1994 | Substantially Equivalent |
| K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | Mar 28, 1994 | Substantially Equivalent |
| K932391 | NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET | Jan 27, 1994 | Substantially Equivalent |