Cleared Traditional

SLT BIPOLAR SHEATH (K981041) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981041 · Surgical Laser Technologies, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
160d
Days
Class 2
Risk

K981041 is an FDA 510(k) clearance for the SLT BIPOLAR SHEATH. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Surgical Laser Technologies, Inc. (Montgomeryville, US). The FDA issued a Cleared decision on August 27, 1998 after a review of 160 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Laser Technologies, Inc. devices

Submission Details

510(k) Number K981041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1998
Decision Date August 27, 1998
Days to Decision 160 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 89d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 17
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K981041.
STRYKER ESSX WITH NAVIGATION MOUNT
K080052 · Stryker Corp. · Oct 2008
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262 · KARL STORZ Endoscopy-America, Inc. · Dec 2005
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · KARL STORZ Endoscopy-America, Inc. · Apr 2001
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
STRYKER TOTAL PERFORMANCE SYSTEM
K943569 · Stryker Corp. · Jan 1995
STRYKER MICRODEBRIDER SYSTEM
K940710 · Stryker Corp. · May 1994