Cleared Traditional

K933201 - AESCULAP TROCAR INSTRUMENT SET

K933201 is an FDA 510(k) clearance for AESCULAP TROCAR INSTRUMENT SET, manufactured by Aesculap, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K933201 · Aesculap, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
74d
Days
Class 2
Risk

K933201 is an FDA 510(k) clearance for the AESCULAP TROCAR INSTRUMENT SET. Classified as Endoscope, Battery-powered And Accessories (product code GCS), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on September 13, 1993 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K933201

510(k) Number K933201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date September 13, 1993
Days to Decision 74 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 131d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCS Device Classification - Class 2, Special Controls

Product Code GCS Endoscope, Battery-powered And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCS Endoscope, Battery-powered And Accessories

All 8
Devices cleared under the same product code (GCS) and FDA review panel - the closest regulatory comparables to K933201.
LAPRASCOPIC GRASPER
K944062 · Instrument Makar, Inc. · Feb 1995
PEANUT WAND, MODIFICATION
K944067 · Ideal Medical, Inc. · Dec 1994
10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT
K932762 · Inman Medical Corp. · Aug 1993
IMC ENDOSCOPIC INSTRUMENT HOLDER
K933371 · Inman Medical Corp. · Aug 1993
LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS
K924134 · Leisegang Medical, Inc. · Jul 1993
GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
K931340 · Baxter Healthcare Corp · Jul 1993
K933201 · AESCULAP TROCAR INSTRUMENT SET
Download PDF FDA Summary Aesculap, Inc.