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510(k) K781089

ONE INCISION BI-POLAR ELECTRO. FORCEPS by Kli — Product Code HIN

K781089 is an FDA 510(k) premarket notification submitted by Kli for the device "ONE INCISION BI-POLAR ELECTRO. FORCEPS". The FDA issued a decision of Substantially Equivalent on July 17, 1978. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. Kli has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1978
Date Received
June 29, 1978
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 Kli

  • K800822 — CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE (June 17, 1980)
  • K800913 — GYNECOLOGICAL CYSTO/URETHROSCOPE (May 14, 1980)
  • K781913 — INSUFFALATOR LAPARAOSCOPIC (December 4, 1978)
  • K781109 — FORCEPS, ELECTROSURGICAL (September 14, 1978)
  • K780954 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K780955 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K772297 — INSUFFLATOR, MODEL G100 & 200 (January 5, 1978)
  • K772242 — LAPAROSCOPY CONSOLE MODEL VIII (December 20, 1977)
  • K772220 — PROBE, COAGULATION ACCESSORY (December 13, 1977)
  • K772185 — LAPAROSCOPE W/REMOVABLE OPTICS (November 30, 1977)

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)
  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K926517 — ELMED LBC 50-P (November 15, 1994)

FDA data resources