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510(k) K010752

AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY by Aesculap, Inc. — Product Code KNF

K010752 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY". The FDA issued a decision of Substantially Equivalent on June 11, 2001. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2001
Date Received
March 13, 2001
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 Aesculap, Inc.

  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K214041 — Aesculap AICON Container (December 30, 2022)
  • K211572 — Aesculap Slim Clip Applier (December 13, 2021)
  • K203739 — ELAN 4 Electro Motor System (August 24, 2021)
  • K202391 — DIR 800 (January 21, 2021)
  • K203461 — Aesculap Caiman 12 Seal and Cut Technology System (December 18, 2020)
  • K202938 — Aesculap Caiman 5 Seal and Cut Technology System (October 30, 2020)
  • K202124 — Aesculap PAS-Port Proximal Anastomosis System (September 2, 2020)

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