MOLLI 2— 510(k) K223107

Substantially Equivalent

Molli Surgical, Inc.

FDA 510(k) clearance K223107 for MOLLI 2, Substantially Equivalent on 2023-01-18. Applicant: Molli Surgical, Inc.. Device class: 2.

Clearance details

Applicant
Molli Surgical, Inc.
Product code
Code NEU
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Toronto, CA
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NEU

product code NEU
Injury
824
Total
824

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.