Cleared Traditional

K991830 - CAPSULAR SHRINKAGE ELECTRODE

K991830 is an FDA 510(k) clearance for CAPSULAR SHRINKAGE ELECTRODE, manufactured by Linvatec Corp.. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K991830 · Linvatec Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
84d
Days
Class 2
Risk

K991830 is an FDA 510(k) clearance for the CAPSULAR SHRINKAGE ELECTRODE. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on August 20, 1999 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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.

FDA 510(k) Submission Details - K991830

510(k) Number K991830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date August 20, 1999
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOS Device Classification - Class 2, Special Controls

Product Code JOS Electrode, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - JOS Electrode, Electrosurgical

All 35
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K991830.
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
K003403 · Highland / Marietta, Inc. · May 2001
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD
K000333 · Triad Surgical Technologies, Inc. · May 2000
ULTRABLATOR ELECTRODE
K993885 · Linvatec Corp. · Feb 2000
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL
K974735 · Aaron Medical Industries · Jun 1998
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
K973554 · Valley Forge Scientific Corp. · Dec 1997
STANDARD & EXTENDED BLADE/NEEDLE/BALL
K971187 · Aaron Medical Industries · May 1997
K991830 · CAPSULAR SHRINKAGE ELECTRODE
Download PDF FDA Summary Linvatec Corp.