FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AESCULAP TROCAR INSTRUMENT SET
K Number: K933201
·
Decision Sep 13, 1993
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
8
Applicant Total
207
Review Days
74
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Basic Information
- Device Name
- AESCULAP TROCAR INSTRUMENT SET
- K Number
- K933201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- July 1, 1993
- Decision Date
- September 13, 1993
- Product Code
- GCS
- 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 |
|---|---|---|---|
| GCS | Endoscope, Battery-Powered And Accessories | FDA class 2 | Gastroenterology, Urology |
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