Cleared Traditional

K961122 - STRYKER KNIFELIGHT

K961122 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 154-day FDA review.

K961122 · Stryker Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K961122

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.

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 K961122.
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, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
XE-LITE
K954263 · Ophthalmic Technologies, Inc. · Oct 1995
GENESIS
K942553 · Burton Medical Products Corp. · Jun 1994
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · Medline Industries, Inc. · Feb 1994
K961122 · STRYKER KNIFELIGHT
Download PDF FDA Summary Stryker Instruments