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510(k) K142525

PK Lap Loop by Olympus Winter & Ibe GmbH — Product Code HIN

K142525 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "PK Lap Loop". The FDA issued a decision of Substantially Equivalent on November 21, 2014. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2014
Date Received
September 8, 2014
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 Olympus Winter & Ibe GmbH

  • K260649 — OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 1 (May 21, 2026)
  • K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep p (September 23, 2025)
  • K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessor (August 18, 2023)
  • K221522 — HF-cables (resusable) (January 19, 2023)
  • K223183 — Light-Guide Cables (January 13, 2023)
  • K213207 — Sheath, Stopcock Accessory (December 22, 2021)
  • K203492 — Instrument tray, for semi-rigid ureteroscope (September 15, 2021)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K203682 — Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer an (May 17, 2021)
  • K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (April 28, 2021)

Other clearances for product code HIN

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

FDA data resources