FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
K Number: K100593
·
Decision Oct 13, 2010
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
6
Review Days
225
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Basic Information
- Device Name
- SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
- K Number
- K100593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lsi Solutions, Inc.
- Date Received
- March 2, 2010
- Decision Date
- October 13, 2010
- Product Code
- GAW
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Lsi Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN230069 | Mi-CHORD System | Jun 11, 2024 | Unknown |
| K222783 | MD Mattress Suture Placement Device | Jan 12, 2024 | Substantially Equivalent |
| K202551 | Cor-Knot Micro | Jun 24, 2021 | Substantially Equivalent |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | Nov 24, 2020 | Substantially Equivalent |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | Jul 13, 2012 | Substantially Equivalent |