EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
FDA 510(k) clearance K980061 · decided 1998-03-02
Clearance details
- K-number
- K980061
- Device name
- EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
- Applicant
- Rocket Medical Plc
- Decision
- Substantially Equivalent
- Date received
- 1998-01-07
- Decision date
- 1998-03-02
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- MFD
- Device class
- 2
- Regulation number
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stamford, CT, US
- 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 |
|---|---|---|
| INSEMINATION CATHETER, MODEL 320301 (K021438) | Labotect Labor-Technik Gottingen | 2002-07-16 |
| THECURVE, ITEM 507 (K012935) | Select Medical Systems, Inc. | 2001-10-11 |
| `THE INSEMINATOR' (PROPOSED) (K984306) | Wallach Surgical Devices, Inc. | 1999-03-01 |
| MEDWORKS VISUALIZATION INSEMINATION CATHETER (K982630) | Medworks Corp. | 1999-01-14 |
| MEDWORKS INSEMINATION CATHETER (K982628) | Medworks Corp. | 1998-08-21 |
| MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER (K972823) | A & A Medical, Inc. | 1997-10-10 |
| TOM CAT F.L., TOM CAT S.L. (K972245) | A & A Medical, Inc. | 1997-08-06 |
| MICROSPAN INSEMINATION SYSTEM (K970750) | Imagyn Medical, Inc. | 1997-05-05 |
| WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM (K964848) | Marlow Surgical Technologies, Inc. | 1997-01-16 |
| GENXCATHETER (K963031) | Genx Intl., Inc. | 1996-10-21 |
| MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST (K962273) | Marlo Surgical Technology | 1996-07-31 |
| ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION (K940176) | Ackrad Laboratories | 1996-04-23 |
Recalls involving this device
No recalls on record reference this clearance.