Cleared Traditional

K911483 - LAPAROSCOPIC TROCAR

K911483 is the FDA 510(k) clearance for LAPAROSCOPIC TROCAR by United States Endoscopy Group, Inc.. It is a Class 2 Cardiovascular device (product code DRC) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K911483 · United States Endoscopy Group, Inc. · Cardiovascular device
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Jul 1991
Decision
89d
Days
Class 2
Risk

K911483 is an FDA 510(k) clearance for the LAPAROSCOPIC TROCAR. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 2, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight 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.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K911483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date July 02, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRC Trocar

All 16
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K911483.
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117 · Merit Medical Systems, Inc. · Oct 2002
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · Arrow Intl., Inc. · Mar 1993
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · E-Z-Em, Inc. · Dec 1991
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707 · United States Surgical, A Division of Tyco Healthc · Jun 1989
DISPOSABLE ANGIOGRAPHY NEEDLES
K890209 · E-Z-Em, Inc. · May 1989
DILUTION KIT, THERMAL, COLD PAC
K781221 · Instrumentation Laboratory CO · Aug 1978