Béa Applicator (BAP-GB-01)
FDA 510(k) clearance K242031 · decided 2025-04-02
Clearance details
- K-number
- K242031
- Device name
- Béa Applicator (BAP-GB-01)
- Applicant
- Stepone Fertility Ltd (T/A Béa Fertility)
- Decision
- Substantially Equivalent
- Date received
- 2024-07-11
- Decision date
- 2025-04-02
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- HDR
- Device class
- 2
- Regulation number
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- London, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FERTI-LILY Conception Cup (K222969) | Rosesta Medical BV | 2023-06-23 |
| OVES CERVICAL CAP (K993953) | Veos , Ltd. | 2000-03-21 |
| IMAGYN INTRAUTERINE INSEMINATION DEVICE (K945131) | Imagyn Medical, Inc. | 1995-05-15 |
| COOK INSEMINATION CUP (K950714) | Cook Urological, Inc. | 1995-05-11 |
| MINISPACE(TM) IUI CATHETER (K902171) | Pharmacia, Inc. | 1990-10-05 |
| COAXIAL CATHETER SET (K902694) | Cook Ob/Gyn | 1990-08-28 |
| INTRAUTERINE INSEMINATION CATHETERS (K896960) | C.R. Bard, Inc. | 1990-06-26 |
| MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (K900316) | Irvine Scientific | 1990-04-16 |
| SPERM SELECT SYSTEM (K900308) | Pharmacia, Inc. | 1990-04-13 |
| DGH A-SAN PROBE HOLDER (K900162) | Jedmed Instrument Co. | 1990-02-16 |
| MODIFIED HAM'S F-10 W/ALBUMIN (K894432) | Irvine Scientific | 1989-09-22 |
| HTF WITH ALBUMIN (CATALOG NO. 9994) (K894405) | Irvine Scientific | 1989-09-22 |
Recalls involving this device
No recalls on record reference this clearance.