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510(k) K863610

THE OB-GYN CONCEPTS VAGINAL ASPIRATOR by Ob/Gyn Concepts, Ltd. — Product Code KOH

K863610 is an FDA 510(k) premarket notification submitted by Ob/Gyn Concepts, Ltd. for the device "THE OB-GYN CONCEPTS VAGINAL ASPIRATOR". The FDA issued a decision of Substantially Equivalent on January 7, 1987. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. Ob/Gyn Concepts, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1987
Date Received
September 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, General Obstetric-Gynecologic
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances by Ob/Gyn Concepts, Ltd.

  • K870528 — OVU-TRAC OVULATION TIMING KIT (May 6, 1987)

Other clearances for product code KOH

  • K000212 — KSEA CHARDONNES MORCELLATION KNIFE (April 21, 2000)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K892693 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (May 11, 1989)
  • K891035 — NEEDLE EXTENSIONS (March 22, 1989)
  • K891049 — ZEPPELIN SCISSORS (March 17, 1989)
  • K840308 — CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (March 5, 1984)
  • K823792 — QUARTZ RETRACTOR/PROBE (January 18, 1983)
  • K812204 — UTERINE MANIPULATORS (October 13, 1981)

FDA data resources