FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Tenex 2nd Generation System
K Number: K241700
·
Decision Nov 18, 2024
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
155
Applicant Total
2
Review Days
158
Basic Information
- Device Name
- Tenex 2nd Generation System
- K Number
- K241700
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trice Medical, Inc.
- Date Received
- June 13, 2024
- Decision Date
- November 18, 2024
- Product Code
- LFL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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Other Clearances by Trice Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Sep 15, 2021 | Substantially Equivalent |