FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SABRE BT BLUNT0TIP SURGICAL TROCAR
K Number: K980804
·
Decision Apr 1, 1998
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
8
Applicant Total
4
Review Days
30
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Basic Information
- Device Name
- SABRE BT BLUNT0TIP SURGICAL TROCAR
- K Number
- K980804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endoscopic Concepts, Inc.
- Date Received
- March 2, 1998
- Decision Date
- April 1, 1998
- Product Code
- FBQ
- 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 |
|---|---|---|---|
| FBQ | Trocar, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
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