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AccuFill® 201.030

by Etex Corp.

AccuFill® 201.030 is a Class II device made by Etex Corp., cleared under FDA 510(k) K190814 on 10 Jun 2019 and listed in FDA GUDID since 2 Nov 2015 (UDI-DI 00889024406476), 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) K190814

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190814 Date10 Jun 2019DecidedStatusActive
United StatesGUDID listing Number00889024406476 UDI-DI Date2 Nov 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190814 decided 10 Jun 2019 Active
  • FDA GUDID UDI-DI 00889024406476 listed 2 Nov 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024406476
  2. Cleared FDA 510(k) K190814

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AccuFill®
Generic name
Synthetic bone graft
Model / Ref / Catalog
201.030
Primary DI / UDI-DI
00889024406476
510(k) Number
FDA product code
MQV
GMDN term
Synthetic bone graft
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution

Related devices

Category: Synthetic bone graft

Cleared under the same submission (K190814)

and 4 more cleared under K190814

Similar devices in this category

Other devices filed under Synthetic bone graft.

Other devices from Etex Corp.

See all devices from Etex Corp. →

Properties

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