Cleared Traditional

K940398 - AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE...

K940398 is the FDA 510(k) clearance for AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE... by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K940398 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Apr 1994
Decision
70d
Days
Class 2
Risk

K940398 is an FDA 510(k) clearance for the AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 70 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K940398 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 27, 1994
Decision Date April 07, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
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 720
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K940398.
LAPAROSCOPY INSTRUMENTS
K931778 · Buckman Co., Inc. · Apr 1994
ACUFEX VIDEO SYSTEM
K940241 · Acufex Microsurgical, Inc. · Apr 1994
MURDOCH LAPAROSCOPE LENS CLEANER
K941092 · Cook, Inc. · Apr 1994
PISTOL SUCTION/IRRIGATION PROBE
K930813 · Origin Medsystems, Inc. · Mar 1994
GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT
K940439 · Conmedcorp · Mar 1994
SCISSOR FOR LAPAROSCOPIC SURGERY GU USE
K925958 · Zinnanti Surgical Instruments, Inc. · Mar 1994