Ovary Forceps
FDA 510(k) K810484 · American V. Mueller
510(k) numberK810484
Submission
- Device name
- Ovary Forceps
- Applicant
- American V. Mueller
Mchenry, IL, US - Received
- February 23, 1981
- Decision date
- March 11, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | Cook Urological, Inc. | 09/03/2009SE |
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | Cook Ob/Gyn | 10/27/2006SE |
| K060289 | Epistat, V-Stat, Models EPISTAT-001-01, V-STAT-001-01KNA · Traditional | Frontline Medical | 07/07/2006SE |
| 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 |
| K001590 | DND 101KNA · Traditional | Urogyn , Ltd. | 08/02/2000SE |
| K990738 | Dr. Jahanger's CutterKNA · Traditional | M.S. Jahanger, MD | 10/29/1999SE |
More from M.S. Jahanger, MD
| 510(k) | Device | Decision |
|---|---|---|
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | 12/18/1987SE |
| K873332 | Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional | 09/08/1987SE |
| K871685 | Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysJXG · Traditional | 06/12/1987SE |
| K864676 | Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional | 12/29/1986SE |
| K862772 | V. Mueller (R) Gooseneck Circular StaplerGAG · Traditional | 08/18/1986SE |
| K861471 | V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional | 06/06/1986SE |
| K854568 | V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional | 12/02/1985SE |
| K854049 | Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional | 11/27/1985SE |
| K851082 | V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional | 07/22/1985SE |
| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | 06/11/1985SE |
Questions and answers
When was Ovary Forceps cleared by the FDA?
Ovary Forceps (K810484) received a 510(k) decision of Substantially Equivalent on March 11, 1981, 16 days after the submission was received.
What is the product code of K810484?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.