Vas Dilator
FDA 510(k) K922192 · Cook Urological, Inc.
510(k) numberK922192
Submission
- Device name
- Vas Dilator
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- May 11, 1992
- Decision date
- August 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KOA – Surgical Instruments, G-U, Manual (And Accessories)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182664 | FiXcisionKOA · Traditional | Agency For Medical Innovations GmbH | 12/07/2018SE |
| K950267 | Urethral Suture GuideKOA · Traditional | Applied Medical Resources | 01/31/1995SE |
| K932465 | Li VasectomyKOA · Traditional | Femcare , Ltd. | 03/02/1994SE |
| K921546 | Vasovasostomy SetKOA · Traditional | Cook Urological, Inc. | 07/02/1993SESK |
| K931181 | Vesitec Suture PasserKOA · Traditional | Vesitec Medical, Inc. | 05/12/1993SE |
| K921304 | DDV LigatorKOA · Traditional | North American Medical, Inc. | 10/05/1992SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | Pilling Co. | 09/23/1992SE |
| K921228 | Benderev Protect-A-Pass NeedleKOA · Traditional | Eimark Labs, Inc. | 09/14/1992SE |
| K896058 | Grasping ForcepsKOA · Traditional | Annex Medical, Inc. | 12/28/1989SE |
| K891352 | Marlow Anal SpeculumKOA · Traditional | Simpson/Basye, Inc. | 06/23/1989SE |
More from Simpson/Basye, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | 05/06/2011SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
Questions and answers
When was Vas Dilator cleared by the FDA?
Vas Dilator (K922192) received a 510(k) decision of Substantially Equivalent on August 7, 1992, 88 days after the submission was received.
What is the product code of K922192?
The FDA product code is KOA – Surgical Instruments, G-U, Manual (And Accessories), a Class I (low risk) device regulated under 21 CFR 876.4730.