Cleared Traditional

K912903 - PERCUTANEOUS RETRACTOR KIT

K912903 is an FDA 510(k) clearance for PERCUTANEOUS RETRACTOR KIT, manufactured by Applied Urology, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K912903 · Applied Urology, Inc. · General & Plastic Surgery device
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Aug 1991
Decision
45d
Days
Class 2
Risk

K912903 is an FDA 510(k) clearance for the PERCUTANEOUS RETRACTOR KIT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Applied Urology, Inc. (Launa Hills, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Applied Urology, Inc. devices

FDA 510(k) Submission Details - K912903

510(k) Number K912903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1991
Decision Date August 16, 1991
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K912903.
DAVIS AND GECK LAPRO-LOOP LIGATURE CARRIER
K912556 · Davis & Geck, Inc. · Sep 1991
MAJOR SET-UP TRAY
K912159 · Medical Device Inspection Co., Inc. · Aug 1991
DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER
K912319 · Davis & Geck, Inc. · Aug 1991
MONOSCOPY(TM) BRANK, HOOK DISSECTOR
K912862 · Dexide, Inc. · Aug 1991
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION
K911105 · United States Surgical, A Division of Tyco Healthc · Aug 1991
MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR
K912750 · Dexide, Inc. · Aug 1991