Cleared Traditional

K984363 - XPS TISSUE ASPIRATION SYSTEM

K984363 is the FDA 510(k) clearance for XPS TISSUE ASPIRATION SYSTEM by Xomed, Inc.. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K984363 · Xomed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
81d
Days
Class 2
Risk

K984363 is an FDA 510(k) clearance for the XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SY.... Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 26, 1999 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 Xomed, Inc. devices

Submission Details

510(k) Number K984363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date February 26, 1999
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 61
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K984363.
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
K043544 · Medela AG · Jan 2005
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K033179 · Medela AG · Oct 2003
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · Medela AG · May 2002
KSEA UNIMAT 45
K981703 · Karl Storz Endoscopy · Aug 1998
EASYGO ASPIRATOR
K971749 · Precision Medical, Inc. · Apr 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
K971107 · Alexander Mfg. Co. · Jun 1997