FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
LOTUS Series 4 Enhanced Shears, LOTUS Series 5
K Number: K221102
·
Decision Dec 15, 2022
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
5
Review Days
245
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Basic Information
- Device Name
- LOTUS Series 4 Enhanced Shears, LOTUS Series 5
- K Number
- K221102
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sra Developments, Ltd.
- Date Received
- April 14, 2022
- Decision Date
- December 15, 2022
- 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 Sra Developments, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Jul 17, 2015 | Substantially Equivalent |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | Dec 19, 2007 | Substantially Equivalent |
| K063531 | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM | Feb 22, 2007 | Substantially Equivalent |
| K032424 | LOTUS | Dec 16, 2003 | Substantially Equivalent |