Pedi Vaginal Aspirator
FDA 510(k) K954903 · Cook Urological, Inc.
510(k) numberK954903
Submission
- Device name
- Pedi Vaginal Aspirator
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- October 25, 1995
- Decision date
- April 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFC – Aspirator, Endocervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1050
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974032 | Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically AspiratorHFC · Traditional | A & A Medical, Inc. | 12/22/1997SE |
| K960263 | Cervical Mucous Aspiration CatheterHFC · Traditional | Cook Urological, Inc. | 08/29/1996SE |
| K954102 | SelectmucusHFC · Traditional | Select Medical Systems, Inc. | 11/21/1995SE |
| K902242 | Endocervical AspiratorHFC · Traditional | Innovative Medical Products, Inc. | 10/09/1990SE |
| K902032 | O. B. Pack IVHFC · Traditional | Customed, Inc. | 09/28/1990SE |
| K902954 | OBER2 Monitor, Eye Movement (Ophthalmic)HFC · Traditional | Permobil AB | 08/23/1990SE |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | Unimar, Inc. | 11/29/1989SE |
| K821134 | DC Pack TMHFC · Traditional | Seamless Hospital Products Co. | 06/22/1982SE |
| K812175 | Endocervical AspiratorHFC · Traditional | Fertility Instrumentation, Inc. | 09/21/1981SE |
| K801238 | Accu-Pap T Zone SamplerHFC · Traditional | Robert Hasselbrack, M.D. | 08/12/1980SE |
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| 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 Pedi Vaginal Aspirator cleared by the FDA?
Pedi Vaginal Aspirator (K954903) received a 510(k) decision of Substantially Equivalent on April 29, 1996, 187 days after the submission was received.
What is the product code of K954903?
The FDA product code is HFC – Aspirator, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.