Panpac Uterine Manipulator Injector, Model Umi 4.5
FDA 510(k) K092980 · Panpac Medical Corporation
510(k) numberK092980
Submission
- Device name
- Panpac Uterine Manipulator Injector, Model Umi 4.5
- Applicant
- Panpac Medical Corporation
Shi-Chih City, Taipei Hsien, TW - Received
- September 28, 2009
- Decision date
- March 11, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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| K242002 | FemVue MINI Saline-Air DeviceLKF · Traditional | Femasys, Inc. | 11/22/2024SE |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0)LKF · Traditional | Li Medical Corporation , Ltd. | 10/16/2024SE |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional | Femasys, Inc. | 09/06/2024SE |
| K222798 | Rejoni Intrauterine CatheterLKF · Traditional | Rejoni, Inc. | 12/16/2022SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | CooperSurgical, Inc. | 10/28/2022SE |
| K220202 | Uterine ElevatOR PRO with OccludOR BalloonLKF · Traditional | The O R Company Pty, Ltd. | 03/31/2022SE |
| K212505 | DUMI ManipulatORLKF · Traditional | The O R Company Pty, Ltd. | 01/10/2022SE |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional | Cook Incorporated | 03/29/2019SE |
More from Cook Incorporated
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|---|---|---|
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | 10/31/2018SE |
| K161106 | Panpac Disposable Vacuum CurettesHGH · Traditional | 01/13/2017SE |
| K153422 | Panpac Disposable Pessary Fitting SetHHW · Special | 07/14/2016SE |
| K132670 | Panpac Inflatable Docut PessaryHHW · Traditional | 06/04/2014SE |
| K130087 | Panpac Word/Bartholin CatheterKNA · Traditional | 01/10/2014SE |
| K130273 | Panpac Vaginal DilatorsHDX · Traditional | 08/08/2013SE |
| K102898 | Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography…LKF · Traditional | 12/15/2011SE |
| K092982 | The Panpac Suction CuretteHHK · Traditional | 07/26/2010SE |
| K092981 | Panpac Vaginal PessaryHHW · Traditional | 07/22/2010SE |
| K092983 | Panpac HSG Catheter SetLKF · Traditional | 06/07/2010SE |
Questions and answers
When was Panpac Uterine Manipulator Injector, Model Umi 4.5 cleared by the FDA?
Panpac Uterine Manipulator Injector, Model Umi 4.5 (K092980) received a 510(k) decision of Substantially Equivalent on March 11, 2010, 164 days after the submission was received.
What is the product code of K092980?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.