Cleared Traditional

K961122 - STRYKER KNIFELIGHT

K961122 is the FDA 510(k) clearance for STRYKER KNIFELIGHT by Stryker Instruments. It is a Class 2 General & Plastic Surgery device (product code FTD) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K961122 · Stryker Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
154d
Days
Class 2
Risk

K961122 is an FDA 510(k) clearance for the STRYKER KNIFELIGHT. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 22, 1996 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Instruments devices

Submission Details

510(k) Number K961122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date August 22, 1996
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K961122.
ATRICURE DISSECTOR
K041681 · AtriCure, Inc. · Jul 2004
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation · Dec 2001
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · Medline Industries, Inc. · Feb 1994
MINOR SURGICAL LIGHT MODEL 180
K841360 · American Sterilizer Co. · Apr 1984
CASTLE & RITTER MINOR SURG. & EXAM LT
K811728 · Sybron Corp. · Jul 1981