The following data is part of a premarket notification filed by Gynex Corp. with the FDA for Gynex Electrodes.
| Device ID | K982739 |
| 510k Number | K982739 |
| Device Name: | GYNEX ELECTRODES |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | GYNEX CORP. 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf GYNEX CORP. 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1999-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| GYNX1410150 | K982739 | 000 |
| GYNX1215151 | K982739 | 000 |
| GYNX1220081 | K982739 | 000 |
| GYNX1220101 | K982739 | 000 |
| GYNX1220151 | K982739 | 000 |
| GYNX1225101 | K982739 | 000 |
| GYNX1225151 | K982739 | 000 |
| GYNX1310101 | K982739 | 000 |
| GYNX1315051 | K982739 | 000 |
| GYNX1320051 | K982739 | 000 |
| GYNX1320071 | K982739 | 000 |
| GYNX1320101 | K982739 | 000 |
| GYNX1215121 | K982739 | 000 |
| GYNX1215081 | K982739 | 000 |
| GYNX1410200 | K982739 | 000 |
| GYNX1412180 | K982739 | 000 |
| GYNX1412200 | K982739 | 000 |
| GYNX1710130 | K982739 | 000 |
| GYNX1710180 | K982739 | 000 |
| GYNX1200001 | K982739 | 000 |
| GYNX1205051 | K982739 | 000 |
| GYNX1210071 | K982739 | 000 |
| GYNX1210101 | K982739 | 000 |
| GYNX1210231 | K982739 | 000 |
| GYNX1215051 | K982739 | 000 |
| GYNX1500011 | K982739 | 000 |
| GYNX1910041 | K982739 | 000 |
| GYNX1910101 | K982739 | 000 |
| GYNXCMR25151 | K982739 | 000 |
| GYNXOCMB2321 | K982739 | 000 |
| GYNXOCMB2521 | K982739 | 000 |
| GYNXOCMR10101 | K982739 | 000 |
| GYNXOCMR15081 | K982739 | 000 |
| GYNXOCMR15121 | K982739 | 000 |
| GYNXOCMR20081 | K982739 | 000 |
| GYNXOCMR20101 | K982739 | 000 |
| GYNXOCMR20131 | K982739 | 000 |
| GYNXOCMR20151 | K982739 | 000 |
| GYNXOCMR25101 | K982739 | 000 |
| GYNXCMR25101 | K982739 | 000 |
| GYNXCMR20151 | K982739 | 000 |
| GYNX2321 | K982739 | 000 |
| GYNX2521 | K982739 | 000 |
| GYNXCMB2321 | K982739 | 000 |
| GYNXCMB2521 | K982739 | 000 |
| GYNXCMR10071 | K982739 | 000 |
| GYNXCMR10101 | K982739 | 000 |
| GYNXCMR15081 | K982739 | 000 |
| GYNXCMR15121 | K982739 | 000 |
| GYNXCMR20081 | K982739 | 000 |
| GYNXCMR20101 | K982739 | 000 |
| GYNXCMR20131 | K982739 | 000 |
| GYNXOCMR25151 | K982739 | 000 |