Cleared Traditional

K930787 - LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT

K930787 is an FDA 510(k) clearance for LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT, manufactured by Advanced Surgical, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K930787 · Advanced Surgical, Inc. · Cardiovascular device
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Jul 1993
Decision
143d
Days
Class 2
Risk

K930787 is an FDA 510(k) clearance for the LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Surgical, Inc. (Princeton, US). The FDA issued a Cleared decision on July 9, 1993 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Surgical, Inc. devices

FDA 510(k) Submission Details - K930787

510(k) Number K930787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 16, 1993
Decision Date July 09, 1993
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 561
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K930787.
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K931514 · Scimed Life Systems, Inc. · Jun 1993
SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI
K931577 · Schneider Intl., Ltd. · Jun 1993
TERUMO CORONARY GUIDE WIRE
K925852 · Terumo Medical Corp. · Jun 1993