Home / 510(k) Clearances / K852075

510(k) K852075

SITE-MALIS BIPOLAR COAGULATOR MODULE by Valley Forge Scientific Corp. — Product Code HQO

K852075 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "SITE-MALIS BIPOLAR COAGULATOR MODULE". The FDA issued a decision of Substantially Equivalent on August 20, 1985. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Valley Forge Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1985
Date Received
May 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Ac-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Valley Forge Scientific Corp.

  • K050364 — MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM (March 9, 2005)
  • K042604 — VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL (October 22, 2004)
  • K032601 — STRYKER INTERVENTIONAL PAIN RF GENERATOR (April 1, 2004)
  • K033499 — MALIS IRRIGATION MODULE 1000 (November 28, 2003)
  • K982229 — BI-DENT (August 13, 1998)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (December 19, 1997)
  • K971986 — VALLEY FORGE BIPOLAR LOOP (August 26, 1997)
  • K964143 — MINI-SYMM BIPOLAR COAGULATOR (January 9, 1997)
  • K955764 — VALLEY FORGE BIPLOAR LOOP (March 1, 1996)
  • K955346 — VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM (December 8, 1995)

Other clearances for product code HQO

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002341 — THERMAL CAUTERY UNIT, MODEL 150 (October 23, 2000)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K971538 — MENTOR GEMINI HEMOSTATIC ERASER (July 14, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K943031 — BIPOLAR ELECTROSURGICAL PENCIL (September 23, 1994)
  • K900913 — ADLER DISPOSABLE BIPOLAR CORD (April 4, 1990)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 1988)
  • K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE (August 12, 1985)

FDA data resources