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Aptos Needle 2G Soft Large

by Aptos, LLC

Aptos Needle 2G Soft Large (AN2GSL) is a Class II device made by Aptos, LLC, cleared under FDA 510(k) K192953 on 27 Aug 2020 and listed in FDA GUDID since 1 Jul 2021 (UDI-DI 04860120240351), 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) K192953

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 Number04860120240351 UDI-DI Date1 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192953 Date27 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192953 decided 27 Aug 2020 Active
  • FDA GUDID UDI-DI 04860120240351 listed 1 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192953
  2. Listed FDA GUDID 04860120240351

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aptos
Generic name
Polyolefin/fluoropolymer suture, monofilament
Model / Ref / Catalog
Aptos Needle 2G Soft Large, AN2GSL
Primary DI / UDI-DI
04860120240351
510(k) Number
FDA product code
GAW
GMDN term
Polyolefin/fluoropolymer suture, monofilament
Device class
Class II
Regulation number
878.5010
GUDID distribution status
In Commercial Distribution
Size
Length — 500 Millimeter

Related devices

Category: Polyolefin/fluoropolymer suture, monofilament

Cleared under the same submission (K192953)

Similar devices in this category

Other devices filed under Polyolefin/fluoropolymer suture, monofilament.

Other devices from Aptos, LLC

See all devices from Aptos, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
Other properties (11, all answered No)