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Mendit Reload Set

by Escala Medical 6 variants

Mendit Reload Set (ES0322) is a Class II device made by Escala Medical, cleared under FDA 510(k) K213783 on 5 Apr 2022 and listed in FDA GUDID since 23 Oct 2023 (UDI-DI 07290019174059), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K213783

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290019174059 UDI-DI Date23 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213783 Date5 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213783 decided 5 Apr 2022 Active
  • FDA GUDID UDI-DI 07290019174059 listed 23 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213783
  2. Listed FDA GUDID 07290019174059

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Soft-tissue/mesh anchor, bioabsorbable
Model / Ref / Catalog
Mendit Reload Set – Permanent Suture (Polypropylene USP 2-0), ES0322
Primary DI / UDI-DI
07290019174059
FDA product code
PBQ
GMDN term
Soft-tissue/mesh anchor, bioabsorbable
Device class
Class II
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
MRI safety
MR Conditional

Related devices

Category: Soft-tissue/mesh anchor, bioabsorbable

Cleared under the same submission (K213783)

and 8 more cleared under K213783

Similar devices

Other devices filed under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).

Other devices from Escala Medical

See all devices from Escala Medical →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)