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510(k) K920838

MEDSURG CIRCUMCISION TRAY by Medsurg Industries, Inc. — Product Code HFK

K920838 is an FDA 510(k) premarket notification submitted by Medsurg Industries, Inc. for the device "MEDSURG CIRCUMCISION TRAY". The FDA issued a decision of Substantially Equivalent on October 15, 1993. The device falls under product code HFK (Mold, Vaginal), a Class II device regulated under 21 CFR 884.3900. Medsurg Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1993
Date Received
February 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mold, Vaginal
Device Class
Class II
Regulation Number
884.3900
Review Panel
OB
Submission Type

Other clearances by Medsurg Industries, Inc.

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K940175 — MEDSURG STERILE O.R. TOWELS (May 26, 1994)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K925558 — INFILTUBE (March 4, 1994)
  • K934971 — STERILE LAPAROTOMY SPONGES (February 7, 1994)
  • K920421 — MEDSURG MARSHMALLOW TRAY (December 13, 1993)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K914037 — MEDSURG O.R. PROCEDURE TRAY (June 22, 1993)
  • K914036 — MEDSURG LAPAROSCOPY TRAY (March 18, 1992)
  • K893938 — CONTINUOUS EPIDURAL ANESTHESIA TRAY (August 7, 1989)

FDA data resources