MD Mattress Suture Placement Device— 510(k) K222783
Substantially EquivalentLsi Solutions, Inc.
FDA 510(k) clearance K222783 for MD Mattress Suture Placement Device, Substantially Equivalent on 2024-01-12. Applicant: Lsi Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Lsi Solutions, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Victor, NY, US
Recent devices under product code GCJ
view allMore clearances from Lsi Solutions, Inc.
view all- DEN230069 — Mi-CHORD System
- K202551 — Cor-Knot Micro
- K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
- K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
- K100593 — SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.