Cleared Traditional

K981041 - SLT BIPOLAR SHEATH

K981041 is an FDA 510(k) clearance for SLT BIPOLAR SHEATH, manufactured by Surgical Laser Technologies, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K981041 · Surgical Laser Technologies, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K981041

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
Combination Product No
PCCP Authorized No
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.

ERL Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K981041.
HUMMER TRAK SYSTEM
K990038 · Stryker Endoscopy · Feb 1999
PNEUMATIC CUTTER SYSTEM
K983050 · Surgical Laser Technologies, Inc. · Nov 1998
XPS DRILL SYSTEM
K983224 · Xomed, Inc. · Oct 1998
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637 · Linvatec Corp. · Jul 1998
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584 · Stryker Endoscopy · Oct 1997
ENT IRRIGATING PUMP (70327700)
K973286 · Gyrus Ent LLC · Sep 1997