Submission Details
| 510(k) Number | K260380 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2026 |
| Decision Date | March 04, 2026 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
Mendit
Mar 2026
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K260380 is an FDA 510(k) clearance for the Mendit, a Fixation, Non-absorbable Or Absorbable, For Pelvic Use (Class II — Special Controls, product code PBQ), submitted by Escala Medical, Ltd. (Misgav, IL). The FDA issued a Cleared decision on March 4, 2026, 27 days after receiving the submission on February 5, 2026. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
Device Classification
| Product Code | PBQ — Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | Attaching Suture Or Stapling Ligaments Of The Pelvic Floor. |
Manufacturer
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