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510(k) K921686

ENDOMED LAPAROSCOPY INSTRUMENTS by Buckman Co., Inc. — Product Code KNF

K921686 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ENDOMED LAPAROSCOPY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on March 30, 1994. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1994
Date Received
April 8, 1992
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 Buckman Co., Inc.

  • K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM (June 25, 1998)
  • K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM (June 8, 1998)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (January 16, 1997)
  • K960451 — WEBB-MORLEY SPINE SYSTEM (April 18, 1996)
  • K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS (January 25, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (October 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)

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