FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
NEEDLE/CANNULA
K Number: K950574
·
Decision Feb 24, 1995
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
14
Review Days
28
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Basic Information
- Device Name
- NEEDLE/CANNULA
- K Number
- K950574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Tri-Med Specialties, Inc.
- Date Received
- January 27, 1995
- Decision Date
- February 24, 1995
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Tri-Med Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971615 | PATTISON ESOPHAGEAL DILATOR | Jul 24, 1997 | Substantially Equivalent |
| K970890 | #ES-32 SUCTION CATHETER 32 FR. | May 23, 1997 | Substantially Equivalent |
| K970982 | T-RX RETRIEVAL FORCEPS | May 9, 1997 | Substantially Equivalent |
| K942918 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | Feb 28, 1995 | Substantially Equivalent |
| K934348 | TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR | Dec 23, 1994 | Substantially Equivalent |
| K945160 | PARACENTESIS NEEDLES/CANNULAS | Nov 14, 1994 | Substantially Equivalent |
| K924549 | TRI-MED QUICK-STEP(TM) RECTAL TUBE | Feb 10, 1994 | Substantially Equivalent |
| K932015 | TRI-MED INFLATABLE ESOPHAGEAL DILATOR | Feb 3, 1994 | Substantially Equivalent |
| K932652 | TRI-MED PARACENTESIS TRAY | Nov 24, 1993 | Unknown |
| K931201 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | Sep 28, 1993 | Substantially Equivalent |