Cleared Traditional

K873892 - SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE

K873892 is an FDA 510(k) clearance for SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS G..., manufactured by Laserguide. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K873892 · Laserguide · Gastroenterology & Urology device
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Feb 1988
Decision
132d
Days
Class 2
Risk

K873892 is an FDA 510(k) clearance for the SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Laserguide (Santa Barbara, US). The FDA issued a Cleared decision on February 2, 1988 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Laserguide devices

FDA 510(k) Submission Details - K873892

510(k) Number K873892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1987
Decision Date February 02, 1988
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 131d · This submission: 132d
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 35
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K873892.
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
K880256 · Sharplan Lasers, Inc. · Apr 1988
ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY
K875039 · Surgilase, Inc. · Apr 1988
MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
K880171 · Cooper Lasersonics, Inc. · Apr 1988
KTP/532 LASER
K873330 · Laserscope · Nov 1987
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
K871865 · Sharplan Lasers, Inc. · Sep 1987
ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
K872630 · Hgm, Inc. · Aug 1987