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510(k) K971986

VALLEY FORGE BIPOLAR LOOP by Valley Forge Scientific Corp. — Product Code HGI

K971986 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "VALLEY FORGE BIPOLAR LOOP". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Valley Forge Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
May 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
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)
  • 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)
  • K951985 — PRECISION BIPOLAR COAGULATOR (May 23, 1995)

Other clearances for product code HGI

  • K202915 — IRIS Thermocoagulator and Digital Colposcope (April 23, 2021)
  • K152843 — Liger Medical HTU-110 (June 24, 2016)
  • K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM (January 3, 2014)
  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K022593 — THOMAS MEDICAL ELECTRODES (November 1, 2002)
  • K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (February 20, 2001)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)

FDA data resources