Cleared Traditional

K963329 - ETHICON ENDOSUTURE SYSTEM

K963329 is the FDA 510(k) clearance for ETHICON ENDOSUTURE SYSTEM by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K963329 · Ethicon, Inc. · General & Plastic Surgery device
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Oct 1996
Decision
63d
Days
Class 2
Risk

K963329 is an FDA 510(k) clearance for the ETHICON ENDOSUTURE SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 63 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 Ethicon, Inc. devices

Submission Details

510(k) Number K963329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1996
Decision Date October 25, 1996
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K963329.
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
K963184 · Olympus America, Inc. · Dec 1996
ENDO VIP
K963323 · Richard Wolf Medical Instruments Corp. · Nov 1996
ENDOCAM
K963046 · Corin USA · Nov 1996
AIRLIFT BALLOON RETRACTON SYSTEM
K962104 · Origin Medsystems, Inc. · Sep 1996
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
K960903 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
EXTRAHAND BALLOON RETRACTOR
K962005 · Origin Medsystems, Inc. · Aug 1996