DND 101
FDA 510(k) K001590 · Urogyn , Ltd.
510(k) numberK001590
Submission
- Device name
- DND 101
- Applicant
- Urogyn , Ltd.
Natick, MA, US - Received
- May 17, 2000
- Decision date
- August 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNA – Instrument, Manual, Specialized Obstetric-Gynecologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | Cook Ob/Gyn | 04/17/2002SE |
| K014248 | DND 202 Manual Urological Digital Needle DriverKNA · Traditional | Urogyn , Ltd. | 03/21/2002SE |
| K990738 | Dr. Jahanger's CutterKNA · Traditional | M.S. Jahanger, MD | 10/29/1999SE |
| K990045 | Beraclamp, Model BC-1KNA · Traditional | Poamax LLC | 05/24/1999SE |
More from Poamax LLC
| 510(k) | Device | Decision |
|---|---|---|
| K014248 | DND 202 Manual Urological Digital Needle DriverKNA · Traditional | 03/21/2002SE |
Questions and answers
When was DND 101 cleared by the FDA?
DND 101 (K001590) received a 510(k) decision of Substantially Equivalent on August 2, 2000, 77 days after the submission was received.
What is the product code of K001590?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.