FDA product code KNA: Instrument, Manual, Specialized Obstetric-Gynecologic
KNA is the FDA product code for instrument, manual, specialized obstetric-gynecologic. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 58 510(k) submissions under KNA, from 34 different applicants. The average 510(k) review took 144 days (median 79).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Manual, Specialized Obstetric-Gynecologic |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Top KNA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 9 | 1989-05-11 |
| Thomasville Medical Assoc. | 8 | 1994-02-25 |
| Cook Urological, Inc. | 3 | 2011-05-06 |
| Precision Surgical Instrument, Inc. | 3 | 1985-01-16 |
| Cook Ob/Gyn | 2 | 2006-10-27 |
29 more applicants have KNA clearances. See the full list in Caduvo.
Most recent KNA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130087 | Panpac Medical Corporation | PANPAC WORD/BARTHOLIN CATHETER | 2014-01-10 | 361 |
| K102141 | Cook Urological, Inc. | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | 2011-05-06 | 281 |
| K093904 | Glenveigh Surgical, LLC | GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER | 2010-04-14 | 113 |
| K082939 | Cook Urological, Inc. | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | 2009-09-03 | 336 |
| K062438 | Cook Ob/Gyn | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | 2006-10-27 | 67 |
Recalls for KNA devices
openFDA lists no recalls for product code KNA.
Frequently asked questions
What is FDA product code KNA?
KNA is the FDA product code for instrument, manual, specialized obstetric-gynecologic. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is KNA?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNA?
Across 58 cleared submissions the average was 144 days from receipt to decision (median 79).
Which companies have the most KNA clearances?
Zinnanti Surgical Instruments, Inc. (9); Thomasville Medical Assoc. (8); Cook Urological, Inc. (3); Precision Surgical Instrument, Inc. (3); Cook Ob/Gyn (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KNA
- Run a recall and safety report across every KNA manufacturer
- Watch product code KNA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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