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510(k) K971565

BICOAG COAGULATING FORCEPS by Everest Medical Corp. — Product Code HIN

K971565 is an FDA 510(k) premarket notification submitted by Everest Medical Corp. for the device "BICOAG COAGULATING FORCEPS". The FDA issued a decision of Substantially Equivalent on March 12, 1998. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. Everest Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1998
Date Received
April 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4150
Review Panel
OB
Submission Type

Other clearances by Everest Medical Corp.

  • K003060 — PLASMAKINETIC GENERATOR (October 31, 2000)
  • K000496 — EVERSHEARS BIPOLAR SCISSORS (April 24, 2000)
  • K993412 — BITX PROBES (March 31, 2000)
  • K994336 — BITX PROBES (February 8, 2000)
  • K955001 — EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS (December 13, 1995)
  • K945975 — EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS (December 21, 1994)
  • K922509 — LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA (October 1, 1992)
  • K922246 — TUBING SET W/ IRRIGATION & ASPIRATION VALVING (September 2, 1992)
  • K920089 — MONOPOLAR COAGULATING POLYPECTOMY SNARE (March 31, 1992)
  • K911787 — MONOPOLAR SPHINCTERTOME (July 19, 1991)

Other clearances for product code HIN

  • K142525 — PK Lap Loop (November 21, 2014)
  • K130305 — LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE (July 24, 2013)
  • K122983 — KSEA BIPOLAR ELECTRODE (June 26, 2013)
  • K122605 — PKS BILL (December 5, 2012)
  • K113080 — TUBALGATOR (June 29, 2012)
  • K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP E (December 2, 2011)
  • K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (September 1, 2011)
  • K990147 — BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.77 (April 16, 1999)
  • K926517 — ELMED LBC 50-P (November 15, 1994)
  • K943776 — COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (November 3, 1994)

FDA data resources