510(k) K982628
- Device
- MEDWORKS INSEMINATION CATHETER
- Applicant
- MEDWORKS CORP.
- 510(k) number
- K982628
- Product code
- MFD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-21
- Date received
- 1998-07-28
- Regulation
- 884.5250
- Classification name
- Cannula, Intrauterine Insemination
- 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
- PAMELA PAPINEAU
- Address
- 50 Brewster St. Pawtucket RI US 02860 02860
FDA Registration Numbers#
- 1216677
- 3014755376
- 9617744
- 3014295858
- 3010155661
- 9610632
- 1825146
- 2246552
- 1820334
- 3005987240
- 1319639
Source Documents#
Other 510(k) Records For Product Code MFD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021438 | INSEMINATION CATHETER, MODEL 320301 | Labotect Labor-Technik Gottingen | 2002-07-16 |
| K012935 | THECURVE, ITEM 507 | Select Medical Systems, Inc. | 2001-10-11 |
| K984306 | `THE INSEMINATOR' (PROPOSED) | Wallach Surgical Devices, Inc. | 1999-03-01 |
| K982630 | MEDWORKS VISUALIZATION INSEMINATION CATHETER | Medworks Corp. | 1999-01-14 |
| K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER | Rocket Medical Plc | 1998-03-02 |
| K972823 | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | A & A Medical, Inc. | 1997-10-10 |
| K972245 | TOM CAT F.L., TOM CAT S.L. | A & A Medical, Inc. | 1997-08-06 |
| K970750 | MICROSPAN INSEMINATION SYSTEM | Imagyn Medical, Inc. | 1997-05-05 |
| K964848 | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM | Marlow Surgical Technologies, Inc. | 1997-01-16 |
| K963031 | GENXCATHETER | Genx Intl., Inc. | 1996-10-21 |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Marlo Surgical Technology | 1996-07-31 |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Ackrad Laboratories | 1996-04-23 |
| K954398 | INSEMI-CATH II | Cook Urological, Inc. | 1995-12-19 |
| K954099 | SELECT IUI | Select Medical Systems, Inc. | 1995-11-22 |
| K953719 | HUMAN TUBAL FLUID | Life Technologies, Inc. | 1995-11-06 |
Legacy Summary#
summary
FDA Review#
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