Cleared Special

K260380 - Mendit (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260380 · Escala Medical, Ltd. · Obstetrics & Gynecology device
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Mar 2026
Decision
27d
Days
Class 2
Risk

K260380 is an FDA 510(k) clearance for the Mendit. Classified as Fixation, Non-absorbable Or Absorbable, For Pelvic Use (product code PBQ), Class II - Special Controls.

Submitted by Escala Medical, Ltd. (Misgav, IL). The FDA issued a Cleared decision on March 4, 2026 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Escala Medical, Ltd. devices

Submission Details

510(k) Number K260380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 160d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PBQ Fixation, Non-absorbable Or Absorbable, For Pelvic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition Attaching Suture Or Stapling Ligaments Of The Pelvic Floor.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Lina Kontos

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.