Ovary Forceps

FDA 510(k) K810484 · American V. Mueller

Substantially Equivalent

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)

Official FDA 510(k) record

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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More from M.S. Jahanger, MD

510(k)DeviceDecision
K873771Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional 12/18/1987SE
K873332Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional 09/08/1987SE
K871685Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysJXG · Traditional 06/12/1987SE
K864676Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional 12/29/1986SE
K862772V. Mueller (R) Gooseneck Circular StaplerGAG · Traditional 08/18/1986SE
K861471V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional 06/06/1986SE
K854568V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional 12/02/1985SE
K854049Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional 11/27/1985SE
K851082V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional 07/22/1985SE
K851974V. 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.