• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Labware, Assisted Reproduction
510(k) Number K262276
Device Name Cyperus
Applicant
Contrario Medical, Inc.
2450 Holcombe Blvd.
Suite 1420
Houston,  TX  77021
Applicant Contact Albert Huang
Correspondent
DuVal & Associates
825 Nicollet Mall
Suite 1820
Minneapolis,  MN  55402
Correspondent Contact Allison Komiyama
Regulation Number884.6160
Classification Product Code
MQK  
Date Received07/06/2026
Decision Date 10/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-