FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
K Number: K920979
·
Decision Mar 23, 1993
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
4
Applicant Total
152
Review Days
386
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Basic Information
- Device Name
- CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
- K Number
- K920979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- March 2, 1992
- Decision Date
- March 23, 1993
- Product Code
- GCQ
- 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 |
|---|---|---|---|
| GCQ | Endoscope, Flexible | FDA class 2 | Gastroenterology, Urology |
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