Cleared Traditional

K871865 - SERIES 2900 SYNTHETIC CONTACT TIPS

K871865 is the FDA 510(k) clearance for SERIES 2900 SYNTHETIC CONTACT TIPS by Sharplan Lasers, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LNK) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K871865 · Sharplan Lasers, Inc. · Gastroenterology & Urology device
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Sep 1987
Decision
118d
Days
Class 2
Risk

K871865 is an FDA 510(k) clearance for the SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on September 8, 1987 after a review of 118 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 Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K871865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1987
Decision Date September 08, 1987
Days to Decision 118 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
12d faster than avg
Panel avg: 130d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K871865.
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
K880256 · Sharplan Lasers, 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
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
K871348 · Sharplan Lasers, Inc. · Jun 1987
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
K871029 · Directed Energy, Inc. · May 1987
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032 · Directed Energy, Inc. · May 1987