The following data is part of a premarket notification filed by Gynex Corp. with the FDA for Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum.
| Device ID | K980247 |
| 510k Number | K980247 |
| Device Name: | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM |
| Classification | Tenaculum, Uterine |
| Applicant | GYNEX CORP. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf GYNEX CORP. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1998-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| GYNXT22300 | K980247 | 000 |
| GYNX32490 | K980247 | 000 |
| GYNX32450 | K980247 | 000 |
| GYNX32400 | K980247 | 000 |
| GYNX32300 | K980247 | 000 |
| GYNX32290 | K980247 | 000 |
| GYNX32270 | K980247 | 000 |
| GYNX32250 | K980247 | 000 |
| GYNX32200 | K980247 | 000 |
| GYNX35000 | K980247 | 000 |
| GYNX35010 | K980247 | 000 |
| GYNX35020 | K980247 | 000 |
| GYNXT22220 | K980247 | 000 |
| GYNXLT22500 | K980247 | 000 |
| GYNXB2300 | K980247 | 000 |
| GYNXB1300 | K980247 | 000 |
| GYNX35360 | K980247 | 000 |
| GYNX35340 | K980247 | 000 |
| GYNX35320 | K980247 | 000 |
| GYNX35300 | K980247 | 000 |
| GYNX32100 | K980247 | 000 |