Cleared Traditional

K843374 - ND-YAG LASER FOR PALLIATION OF GI MALIGN

K843374 is an FDA 510(k) clearance for ND-YAG LASER FOR PALLIATION OF GI MALIGN, manufactured by Endo Lase, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K843374 · Endo Lase, Inc. · Gastroenterology & Urology device
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Oct 1984
Decision
35d
Days
Class 2
Risk

K843374 is an FDA 510(k) clearance for the ND-YAG LASER FOR PALLIATION OF GI MALIGN. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Endo Lase, Inc. (Walker, US). The FDA issued a Cleared decision on October 2, 1984 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4810 - 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.

View all Endo Lase, Inc. devices

FDA 510(k) Submission Details - K843374

510(k) Number K843374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date October 02, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 131d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNK Device Classification - Class 2, Special Controls

Product Code LNK Laser For Gastro-urology Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
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 - LNK Laser For Gastro-urology Use

All 34
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K843374.
ND. YAG LASER RECTAL PATHOLOGY
K844460 · Endo Lase, Inc. · Jan 1985
LASER FOR GENITOURINARY APPLIC. 4000
K843240 · Cooper Lasersonics, Inc. · Oct 1984
ND-YAG LASER FOR UROLOGICAL SURGERY
K843293 · Endo Lase, Inc. · Oct 1984
COOPER LASERSONICS, 8000 ND.YAGLASER
K841869 · Cooper Lasersonics, Inc. · Aug 1984
YAG LASER 8000 - LOWER GI APPLICAT
K840142 · Cooper Lasersonics, Inc. · May 1984
MEDILAS LASER
K833557 · Endo Lase, Inc. · Feb 1984