FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC DELIVERY SYSTEM
K Number: K913172
·
Decision Sep 6, 1991
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
8
Review Days
51
Basic Information
- Device Name
- ENDOSCOPIC DELIVERY SYSTEM
- K Number
- K913172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MEDCO PRODUCTS, CO., INC.
- Date Received
- July 17, 1991
- Decision Date
- September 6, 1991
- 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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Other Clearances by MEDCO PRODUCTS, CO., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K932466 | MEDCHEM SURGICAL DELIVERY SYSTEM | Aug 9, 1993 | Substantially Equivalent |
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| K844580 | MEDCOLATOR MODEL HVX | Feb 25, 1985 | Substantially Equivalent |
| K842712 | MEDCOLATOR MODEL GX | Sep 19, 1984 | Substantially Equivalent |
| K822829 | ROTARY VASCULAR KNIFE | Nov 17, 1982 | Substantially Equivalent |