Device Desk

Private service · Not FDA

FDA device establishment · Sunnyvale, 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-3043236281As of September 30, 2026

AXORA MEDICAL, INC.

Registration 3043236281FEI 3043236281Sunnyvale, CA

Owner/operator: Axora Medical, Inc.

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

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
11
Added, last 12 months
11

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 11

CodeDeviceClassRegulationPremarket
MNBDevice, Thermal Ablation, EndometrialUnknownAdded Feb 21, 2026Class 3—P000040
MNBDevice, Thermal Ablation, EndometrialUnknownAdded Feb 21, 2026Class 3—P140013
HIHHERizon RD5 Resecting DeviceHysteroscope (And Accessories)Added Sep 17, 2026Class 221 CFR 884.1690K260984
HIHHysteroscope (And Accessories)Obstetrics/GynecologyAdded Feb 21, 2026Class 221 CFR 884.1690K160751
HIHHysteroscope (And Accessories)Obstetrics/GynecologyAdded Feb 21, 2026Class 221 CFR 884.1690K191538
HIGInsufflator, HysteroscopicObstetrics/GynecologyAdded Feb 21, 2026Class 221 CFR 884.1700K233710
PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, BipolarObstetrics/GynecologyAdded Feb 20, 2026Class 221 CFR 884.1710K141848
PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, BipolarObstetrics/GynecologyAdded Feb 21, 2026Class 221 CFR 884.1710K233710
HDQDilator, Cervical, Fixed SizeObstetrics/GynecologyAdded Feb 21, 2026Class 121 CFR 884.4530—
NWWHysteroscope AccessoriesObstetrics/GynecologyAdded Feb 21, 2026Class 121 CFR 884.1690—
FOXStand, InfusionGeneral HospitalAdded Feb 9, 2026Class 121 CFR 880.6990—

What changed

  • Feb 21, 2026Listing added: MNB — Device, Thermal Ablation, Endometrial (P000040)
  • Feb 21, 2026Listing added: MNB — Device, Thermal Ablation, Endometrial (P140013)
  • Sep 17, 2026Listing added: HIH — HERizon RD5 Resecting Device (K260984)
  • Feb 21, 2026Listing added: HIH — Hysteroscope (And Accessories) (K160751)
  • Feb 21, 2026Listing added: HIH — Hysteroscope (And Accessories) (K191538)
  • Feb 21, 2026Listing added: HIG — Insufflator, Hysteroscopic (K233710)
  • Feb 20, 2026Listing added: PGT — Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar (K141848)
  • Feb 21, 2026Listing added: PGT — Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar (K233710)
  • Feb 21, 2026Listing added: HDQ — Dilator, Cervical, Fixed Size
  • Feb 21, 2026Listing added: NWW — Hysteroscope Accessories
  • Feb 9, 2026Listing added: FOX — Stand, Infusion
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.

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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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