Home / 510(k) Clearances / K915569

510(k) K915569

UMBILICAL CLAMP by Gam Industries, Inc. — Product Code HFW

K915569 is an FDA 510(k) premarket notification submitted by Gam Industries, Inc. for the device "UMBILICAL CLAMP". The FDA issued a decision of Substantially Equivalent on September 23, 1992. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Gam Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1992
Date Received
December 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Umbilical
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Gam Industries, Inc.

  • K941641 — DISPOSABLE EMERGENCY OBSTETRICAL KIT (October 3, 1994)
  • K941336 — COMBO MASK (September 9, 1994)
  • K942021 — MOUTH TO MOUTH BREATHER (June 22, 1994)
  • K936050 — JAW SPREADER (March 24, 1994)
  • K930401 — ALUMINUM FOIL (May 12, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)

Other clearances for product code HFW

  • K041332 — JOEY CLAMP OPENING TOOL (June 25, 2004)
  • K033846 — KAEN YIH UMBILICAL CORD CLAMP (March 11, 2004)
  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K021055 — BUSSE UMBILICAL CORD CLAMP CUTTER (April 29, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K011621 — KOALA CLAMP, KOALA CLAMP AND CUTTER (August 10, 2001)
  • K010695 — KOALA CLAMP (May 3, 2001)
  • K010835 — POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLA (April 30, 2001)
  • K000227 — UMBICUT (April 27, 2000)
  • K994367 — UMBILICAL CORD CLAMP (March 17, 2000)

FDA data resources