LKFClass II
Cannula, Manipulator/Injector, Uterine
21 CFR 884.4530 / Obstetrics/Gynecology
LKF is the FDA product code for Cannula, Manipulator/Injector, Uterine, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold 87 510(k) clearances under this code, the most recent dated , and 13 recalls.
Classification record
- Product code
- LKF
- Device name
- Cannula, Manipulator/Injector, Uterine
- Regulation
- 21 CFR 884.4530
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 87
- Ingested recalls
- 13
Clearances, product code LKF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1994 | 9 |
| 1995 | 10 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 5 |
| 2002 | 6 |
| 2003 | 1 |
| 2004 | 3 |
| 2006 | 1 |
| 2007 | 3 |
| 2009 | 2 |
| 2010 | 6 |
| 2011 | 3 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 5 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 1 |
| 2022 | 4 |
| 2024 | 3 |
| 2025 | 2 |
Applicants with the most clearances
Product code LKF| Applicant | Clearances |
|---|---|
| Cook Incorporated | 7 |
| Femasys Inc. | 7 |
| Ackrad Laboratories | 6 |
| Biomerics | 4 |
| CooperSurgical, Inc. | 4 |
| Panpac Medical Corporation | 4 |
| A & A Medical, Inc. | 3 |
| ConMed Corporation | 3 |
| Zinnanti Surgical Instruments, Inc. | 3 |
| Clinical Innovations, LLC | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.