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510(k) K790851

VAGI-PRESS #401 by C. Intl. — Product Code KOH

K790851 is an FDA 510(k) premarket notification submitted by C. Intl. for the device "VAGI-PRESS #401". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. C. Intl. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
May 4, 1979
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 C. Intl.

  • K792494 — CATHETERIZATION FORCEP (December 20, 1979)
  • K790855 — SURGICAL DRAPE CLIP #201 (August 3, 1979)
  • K790853 — EASY-SPEC (July 30, 1979)
  • K790852 — VAGI-SPEC (July 30, 1979)
  • K790854 — FORCEPS #101 AND #102 (June 5, 1979)
  • K790856 — PROCTOSCOPE #501 (May 29, 1979)

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)
  • K892693 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (May 11, 1989)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891035 — NEEDLE EXTENSIONS (March 22, 1989)
  • K891049 — ZEPPELIN SCISSORS (March 17, 1989)
  • K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (January 7, 1987)
  • K840308 — CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (March 5, 1984)
  • K823792 — QUARTZ RETRACTOR/PROBE (January 18, 1983)

FDA data resources