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510(k) K780955

SCISSORS, HOOK, ELECTROSURGICAL by Kli — Product Code KNF

K780955 is an FDA 510(k) premarket notification submitted by Kli for the device "SCISSORS, HOOK, ELECTROSURGICAL". The FDA issued a decision of Substantially Equivalent on June 22, 1978. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Kli has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1978
Date Received
June 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
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)
  • K781089 — ONE INCISION BI-POLAR ELECTRO. FORCEPS (July 17, 1978)
  • K780954 — 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 KNF

  • K250705 — Sonata Transcervical Fibroid Ablation System 2.2 (April 2, 2025)
  • K240503 — Sonata Transcervical Fibroid Ablation System 2.2 (July 17, 2024)
  • K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (December 21, 2023)
  • K222304 — Sonata Transcervical Fibroid Ablation System 2.2 (November 8, 2022)
  • K211535 — Sonata Transcervical Fibroid Ablation System 2.2 (June 17, 2021)
  • K193516 — Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (May 4, 2020)
  • K173703 — Sonata Sonography-Guided Transcervical Fibroid Ablation System (August 15, 2018)
  • K132135 — LINA GOLD LOOP HC (January 31, 2014)
  • K121343 — MODULAP LOOP (June 14, 2013)
  • K103726 — JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (February 8, 2012)

FDA data resources