Home / 510(k) Clearances / K970282

510(k) K970282

MEDLINE CIRCUMCISION TRAY by Medline — Product Code HFX

K970282 is an FDA 510(k) premarket notification submitted by Medline for the device "MEDLINE CIRCUMCISION TRAY". The FDA issued a decision of Substantially Equivalent on March 6, 1997. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Medline has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1997
Date Received
January 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Medline

  • K120156 — PUREIMAGE ULTRASOUND TRANSMISSION GEL (February 8, 2012)
  • K051378 — POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DR (August 3, 2005)
  • K010825 — MEDLINE STERISET STERILIZATION CONTAINER (May 8, 2001)
  • K990463 — MEDLINE EXCEL WHEELCHAIRS (March 15, 1999)
  • K963504 — MEDLINE OPEN END FINGER CONTROL MITT (October 29, 1996)
  • K963452 — MEDLINE ZIPPER SLEEVED VEST (October 18, 1996)
  • K951736 — LOCK-UP (July 5, 1995)
  • K932033 — LAPAROSCOPIC SURGERY INSTRUMENTS (June 19, 1995)
  • K932060 — MARTIN COLD LIGHT FOUNTAIN (March 30, 1994)
  • K915502 — MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES (April 29, 1992)

Other clearances for product code HFX

  • K251687 — Konig Bell Circumcision Clamp (February 25, 2026)
  • K221356 — Wee Bell (February 2, 2023)
  • K212911 — Konig Mogen Clamp (November 18, 2022)
  • K151095 — Circumplast Circumcision Device (September 18, 2015)
  • K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP (April 20, 2015)
  • K131373 — SHANGRING (June 25, 2013)
  • K121789 — SHANGRING (August 3, 2012)
  • K103695 — PREPEX SYSTEM (January 10, 2012)
  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)

FDA data resources