Cleared Traditional

K934724 - AESCULAP TROCAR INSTRUMENT SET

K934724 is an FDA 510(k) clearance for AESCULAP TROCAR INSTRUMENT SET, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FBQ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K934724 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
83d
Days
Class 2
Risk

K934724 is an FDA 510(k) clearance for the AESCULAP TROCAR INSTRUMENT SET. Classified as Trocar, Gastro-urology (product code FBQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 23, 1993 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.5090 - the FDA general and plastic surgery 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 - K934724

510(k) Number K934724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1993
Decision Date December 23, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBQ Device Classification - Class 2, Special Controls

Product Code FBQ Trocar, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FBQ Trocar, Gastro-urology

All 8
Devices cleared under the same product code (FBQ) and FDA review panel - the closest regulatory comparables to K934724.
LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT
K944640 · Gabris Surgical Corp. · Oct 1994
GABRIS LAPAROSCOPIC SURGICAL KITS
K944104 · Gabris Surgical Corp. · Sep 1994
AUTO SUTURE MODIFIED GRIP
K942885 · United States Surgical, A Division of Tyco Healthc · Aug 1994
TROCAR DISPOSABLE
K904638 · L.A.S.E.R., Inc. · Feb 1991
AUTO SUTURE SURGIPORT SPIRAL SLEEVE
K900123 · United States Surgical, A Division of Tyco Healthc · Apr 1990
ENDOPORT EROCAR
K841716 · Endotherapeutics · Jun 1984
K934724 · AESCULAP TROCAR INSTRUMENT SET
Download PDF FDA Summary Aesculap, Inc.