The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Word Bartholin Gland Catheter (final Trade Name Not Yet Determined).
| Device ID | K102141 |
| 510k Number | K102141 |
| Device Name: | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Contact | Cindy Foote |
| Correspondent | Cindy Foote COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2011-05-06 |
| Summary: | summary |