FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAVIS+GECK REUSABLE TRTOCARS
K Number: K930254
·
Decision Mar 24, 1994
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
45
Review Days
429
Basic Information
- Device Name
- DAVIS+GECK REUSABLE TRTOCARS
- K Number
- K930254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DAVIS & GECK, INC.
- Date Received
- January 19, 1993
- Decision Date
- March 24, 1994
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K970857 | ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO | Nov 5, 1997 | Substantially Equivalent |
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| K972566 | DEXON VIOLET | Aug 14, 1997 | Substantially Equivalent |
| K962971 | POLYPROPYLENE MESH (VARIOUS SIZES) | Sep 16, 1996 | Substantially Equivalent |