Cleared Traditional

K911475 - LAPAROSCOPIC VESSEL ARTICULATOR

K911475 is an FDA 510(k) clearance for LAPAROSCOPIC VESSEL ARTICULATOR, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Cardiovascular device with product code DWP cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K911475 · United States Endoscopy Group, Inc. · Cardiovascular device
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Jul 1991
Decision
89d
Days
Class 2
Risk

K911475 is an FDA 510(k) clearance for the LAPAROSCOPIC VESSEL ARTICULATOR. Classified as Dilator, Vessel, Surgical (product code DWP), 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 870.4475 - 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

FDA 510(k) Submission Details - K911475

510(k) Number K911475 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.

DWP Device Classification - Class 2, Special Controls

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
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 - DWP Dilator, Vessel, Surgical

All 13
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K911475.
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · Fehling Surgical Instruments, Inc. · Apr 2023
Geomed Vascular Dilators
K183438 · Geomed Medizin-Technik GmbH & Co. · Sep 2019
RDI CARDIAC INSULATION PAD
K960312 · R D Intl. · Apr 1996
ROBICSEK PROBE/RETRACTOR
K910682 · Bio-Vascular, Inc. · May 1991
FLO-RESTER(R) VESSEL SIZER
K905159 · Bio-Vascular, Inc. · Feb 1991
FOGARTY VESSEL CALIBRATOR
K902143 · Baxter Healthcare Corp · Oct 1990