Cleared Traditional

K981717 - STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR

K981717 is an FDA 510(k) clearance for STRYKER KNIFELIGHT, manufactured by Stryker Instruments. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K981717 · Stryker Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
46d
Days
Class 2
Risk

K981717 is an FDA 510(k) clearance for the STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on June 30, 1998 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 - K981717

510(k) Number K981717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1998
Decision Date June 30, 1998
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTD Device Classification - Class 2, Special Controls

Product Code FTD Lamp, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 - FTD Lamp, Surgical

All 28
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K981717.
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation · Dec 2001
SOLA 700,SOLA 500, SOLA 300
K010724 · Drager Medizintechnik GmbH · Jun 2001
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
K003423 · St. Francis Medical Equipment Co., Ltd. · Feb 2001
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996
XE-LITE
K954263 · Ophthalmic Technologies, Inc. · Oct 1995
GENESIS
K942553 · Burton Medical Products Corp. · Jun 1994
K981717 · STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
Download PDF FDA Summary Stryker Instruments