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510(k) K933201

AESCULAP TROCAR INSTRUMENT SET by Aesculap, Inc. — Product Code GCS

K933201 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP TROCAR INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on September 13, 1993. The device falls under product code GCS (Endoscope, Battery-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1993
Date Received
July 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Battery-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
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 GCS

  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K944067 — PEANUT WAND, MODIFICATION (December 8, 1994)
  • K932762 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (August 31, 1993)
  • K933371 — IMC ENDOSCOPIC INSTRUMENT HOLDER (August 6, 1993)
  • K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (July 2, 1993)
  • K931340 — GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR (July 1, 1993)
  • K925276 — M.I.S. TROCAR-CANNULA (May 24, 1993)
  • K921006 — LAPAROSCOPIC RETRACTOR SYSTEM (July 28, 1992)

FDA data resources