Cleared Traditional

K945474 - SCANLAN THORACOSCOPIC SCISSORS

K945474 is the FDA 510(k) clearance for SCANLAN THORACOSCOPIC SCISSORS by Scanlan Intl., Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K945474 · Scanlan Intl., Inc. · General & Plastic Surgery device
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Dec 1994
Decision
27d
Days
Class 2
Risk

K945474 is an FDA 510(k) clearance for the SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 27 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 Scanlan Intl., Inc. devices

Submission Details

510(k) Number K945474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date December 05, 1994
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 694
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K945474.
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
K945751 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944299 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES
K944672 · Boston Scientific Corp · Dec 1994
COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANER
K944303 · Cook Urological, Inc. · Dec 1994
HI-Q HAND INSTRUMENTS- UROLOGY
K944201 · Olympus America, Inc. · Nov 1994
TROCAR ( ACCESORY)
K945457 · United States Surgical, A Division of Tyco Healthc · Nov 1994