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510(k) K841682

UTERINE INJECTOR 4.0MM by Humi Corp. — Product Code HES

K841682 is an FDA 510(k) premarket notification submitted by Humi Corp. for the device "UTERINE INJECTOR 4.0MM". The FDA issued a decision of Substantially Equivalent on July 3, 1984. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Humi Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1984
Date Received
April 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Device Class
Class II
Regulation Number
884.1300
Review Panel
OB
Submission Type

Other clearances by Humi Corp.

  • K841681 — UTERINE MANIPULATOR 4.5MM (April 23, 1984)

Other clearances for product code HES

  • K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (April 21, 2014)
  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)
  • K903209 — MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (December 21, 1990)
  • K903208 — MAXI-FLOW INSUFFLATOR TUBING SET (December 17, 1990)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K901413 — CORE DISPOSABLE INSUFFLATION TUBING (September 24, 1990)
  • K891290 — SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER (May 23, 1989)
  • K890869 — BARD HYSTEROSALPINGOGRAPHY CATHETERS (April 25, 1989)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K873515 — UTERINE INJECTOR 2MM (September 29, 1987)

FDA data resources