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Fastloop™ White DFX24SLW

by Dunamis Medical LLC

Fastloop™ White DFX24SLW is a Class II device made by Dunamis Medical LLC, cleared under FDA 510(k) K192490 on 30 Mar 2020 and listed in FDA GUDID since 3 Mar 2022 (UDI-DI 10854629006847), active as of 23 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 23 Oct 2026

Documents

510(k) K192490

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10854629006847 UDI-DI Date3 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192490 Date30 Mar 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192490 decided 30 Mar 2020 Active
  • FDA GUDID UDI-DI 10854629006847 listed 3 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192490
  2. Listed FDA GUDID 10854629006847

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fastloop™ White
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / reference
DFX24SLW
Primary DI / UDI-DI
10854629006847
510(k) Number
FDA product code
GAT
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K192490)

and 8 more cleared under K192490

Similar devices in this category

Other devices filed under Polyester suture, non-bioabsorbable, multifilament.

Other devices from Dunamis Medical LLC

See all devices from Dunamis Medical LLC →

Properties

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