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510(k) K242031

Device
Béa Applicator (BAP-GB-01)
Applicant
Stepone Fertility Ltd (T/A Béa Fertility)
510(k) number
K242031
Product code
HDR
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-02
Date received
2024-07-11
Regulation
884.5250
Classification name
Cap, Cervical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tom Littleford
Address
71-75 Shelton St. Covent Garden London GB WC2H 9JQ WC2H 9JQ

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HDR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222969FERTI-LILY Conception CupRosesta Medical BV2023-06-23
K993953OVES CERVICAL CAPVeos , Ltd.2000-03-21
K945131IMAGYN INTRAUTERINE INSEMINATION DEVICEImagyn Medical, Inc.1995-05-15
K950714COOK INSEMINATION CUPCook Urological, Inc.1995-05-11
K902171MINISPACE(TM) IUI CATHETERPharmacia, Inc.1990-10-05
K902694COAXIAL CATHETER SETCook Ob/Gyn1990-08-28
K896960INTRAUTERINE INSEMINATION CATHETERSC.R. Bard, Inc.1990-06-26
K900316MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPESIrvine Scientific1990-04-16
K900308SPERM SELECT SYSTEMPharmacia, Inc.1990-04-13
K900162DGH A-SAN PROBE HOLDERJedmed Instrument Co.1990-02-16
K894405HTF WITH ALBUMIN (CATALOG NO. 9994)Irvine Scientific1989-09-22
K894432MODIFIED HAM'S F-10 W/ALBUMINIrvine Scientific1989-09-22
K894264KDF-2.3Unimar, Inc.1989-08-15
K890301SHEPARD INTRAUTERINE INSEMINATION CATHETERCook Ob/Gyn1989-03-31
K884696RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SETLaboratoire Ccd C/O Washington Regulatory Services1989-01-27