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510(k) K812204

UTERINE MANIPULATORS by Reznik Instruments — Product Code KOH

K812204 is an FDA 510(k) premarket notification submitted by Reznik Instruments for the device "UTERINE MANIPULATORS". The FDA issued a decision of Substantially Equivalent on October 13, 1981. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. Reznik Instruments has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1981
Date Received
August 4, 1981
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 Reznik Instruments

  • K812205 — FORCEP (October 26, 1981)
  • K812201 — PHOTOGRAPHIC EQUIPMENT (October 19, 1981)
  • K812203 — ELECTROSURGICAL UNIT (October 13, 1981)
  • K812199 — TROCAR & TROCAR SLEEVES (October 13, 1981)
  • K812206 — LAPAROSCOPE (October 13, 1981)
  • K812202 — FIBER OPTIC LIGHT SOURCE (September 29, 1981)
  • K812200 — INSUFFLATOR (September 29, 1981)
  • K812198 — ACCESSORIES(PROBES, SUCTION TUBES, ETC.) (September 11, 1981)

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)
  • 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