Cleared Traditional

K955490 - LAPAROSCOPIC KNITTER

K955490 is an FDA 510(k) clearance for LAPAROSCOPIC KNITTER, manufactured by Core Dynamics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K955490 · Core Dynamics, Inc. · General & Plastic Surgery device
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Jan 1996
Decision
80d
Days
Class 2
Risk

K955490 is an FDA 510(k) clearance for the LAPAROSCOPIC KNITTER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 80 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 Core Dynamics, Inc. devices

FDA 510(k) Submission Details - K955490

510(k) Number K955490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1995
Decision Date January 22, 1996
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 K955490.
TROGARD TROCAR DIALATING TROCAR SYSTEM
K961175 · Conmedcorp · Apr 1996
MAHLER ABDOMINAL WALL ELEVATOR
K960878 · Cook Urological, Inc. · Mar 1996
OTV-S5 OES VIDEO SYSTEM
K955404 · Olympus America, Inc. · Feb 1996
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
K943307 · Olympus America, Inc. · Dec 1995
AUTO SUTURE SUTURE CLOSURE
K954853 · United States Surgical, A Division of Tyco Healthc · Dec 1995
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]
K954174 · Origin Medsystems, Inc. · Nov 1995