Device Desk

Private service · Not FDA

FDA device establishment · Irvine, CA

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3039103971As of September 30, 2026

CGBIO USA, INC.

Registration 3039103971FEI 3039103971Irvine, CA

Owner/operator: CGBIO USA, Inc.

  • Repack or Relabel Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
10
Added, last 12 months
10

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 10

CodeDeviceClassRegulationPremarket
GXNEASYMADE-TIPlate, Cranioplasty, Preformed, Non-AlterableAdded May 13, 2026Class 221 CFR 882.5330K252251
FZO[Target] TCH0001L Straight Chisel 5mmChisel, Surgical, ManualAdded Jan 27, 2026Class 121 CFR 878.4800—
FZS[Target] TCU0002 Bone Curette 3mm BishopCurette, Surgical, General UseAdded Jan 27, 2026Class 121 CFR 878.4800—
GEG[Target] TFR0001 FreerElevator, Surgical, General & Plastic SurgeryAdded Jan 27, 2026Class 121 CFR 878.4800—
HTS[Target] TIK0001L Indian Knife(Long)Knife, OrthopedicAdded Jan 27, 2026Class 121 CFR 888.4540—
HXL[Target] TML0001 MalletMalletAdded Jan 27, 2026Class 121 CFR 878.4800—
LXH[Target] TDI0001 DilatorOrthopedic Manual Surgical InstrumentAdded Jan 27, 2026Class 121 CFR 888.4540—
LRY[Target] TFP0001 Foraminal Punch 2mmPunch, SurgicalAdded Jan 27, 2026Class 121 CFR 878.4800—
GAD[Target] TRR0001 Root RetractorRetractorAdded Jan 27, 2026Class 121 CFR 878.4800—
HTX[Target] TMP0001 Micro Pituitary 2mm StraightRongeurAdded Jan 27, 2026Class 121 CFR 888.4540—

What changed

  • May 13, 2026Listing added: GXN — EASYMADE-TI (K252251)
  • Jan 27, 2026Listing added: FZO — [Target] TCH0001L Straight Chisel 5mm
  • Jan 27, 2026Listing added: FZS — [Target] TCU0002 Bone Curette 3mm Bishop
  • Jan 27, 2026Listing added: GEG — [Target] TFR0001 Freer
  • Jan 27, 2026Listing added: HTS — [Target] TIK0001L Indian Knife(Long)
  • Jan 27, 2026Listing added: HXL — [Target] TML0001 Mallet
  • Jan 27, 2026Listing added: LXH — [Target] TDI0001 Dilator
  • Jan 27, 2026Listing added: LRY — [Target] TFP0001 Foraminal Punch 2mm
  • Jan 27, 2026Listing added: GAD — [Target] TRR0001 Root Retractor
  • Jan 27, 2026Listing added: HTX — [Target] TMP0001 Micro Pituitary 2mm Straight
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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