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510(k) K921732

MINOR LAP SET by Medikmark, Inc. — Product Code KOH

K921732 is an FDA 510(k) premarket notification submitted by Medikmark, Inc. for the device "MINOR LAP SET". The FDA issued a decision of Substantially Equivalent on Jun 15, 1994. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. Medikmark, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 15, 1994
Date Received
Apr 10, 1992
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 Medikmark, Inc.

  • K953474 — IV START KIT (Oct 2, 1995)
  • K923960 — UPPER EXTERMITY DRAPE KIT (Oct 7, 1994)
  • K921733 — TRACHEOSTOMY CARE TRAY (Jun 15, 1994)
  • K921730 — C-SECTION PACK (Jun 15, 1994)
  • K920339 — DRESSING CHANGE TRAY (Apr 23, 1992)
  • K920341 — LACERATION TRAYS (Apr 23, 1992)
  • K920340 — SUTURE REMOVAL KIT (Apr 23, 1992)

Other clearances for product code KOH

  • K000212 — KSEA CHARDONNES MORCELLATION KNIFE (Apr 21, 2000)
  • K921730 — C-SECTION PACK (Jun 15, 1994)
  • K892693 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (May 11, 1989)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891035 — NEEDLE EXTENSIONS (Mar 22, 1989)
  • K891049 — ZEPPELIN SCISSORS (Mar 17, 1989)
  • K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (Jan 7, 1987)
  • K840308 — CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (Mar 5, 1984)
  • K823792 — QUARTZ RETRACTOR/PROBE (Jan 18, 1983)
  • K812204 — UTERINE MANIPULATORS (Oct 13, 1981)

FDA data resources