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510(k) K111059

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) by Gyrus Acmi, Inc. — Product Code HIN

K111059 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)". The FDA issued a decision of Substantially Equivalent on September 1, 2011. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2011
Date Received
April 18, 2011
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 Gyrus Acmi, Inc.

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-us (March 25, 2024)
  • K231327 — POWERSEAL Sealer and Divider (October 25, 2023)
  • K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperP (January 27, 2023)
  • K212650 — Celeris, Disposable Sinus Debrider (January 19, 2022)
  • K213831 — Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (January 4, 2022)
  • K211401 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed (June 3, 2021)
  • K181696 — ChitoZolve (November 30, 2018)
  • K180086 — Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (March 8, 2018)
  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)

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)
  • 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)
  • K943776 — COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (November 3, 1994)

FDA data resources