Cleared Traditional

K964672 - SUTURE APPLICATOR

K964672 is an FDA 510(k) clearance for SUTURE APPLICATOR, manufactured by Laurus Medical Group. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K964672 · Laurus Medical Group · General & Plastic Surgery device
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Feb 1997
Decision
78d
Days
Class 2
Risk

K964672 is an FDA 510(k) clearance for the SUTURE APPLICATOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Laurus Medical Group (Irvine, US). The FDA issued a Cleared decision on February 7, 1997 after a review of 78 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 Laurus Medical Group devices

FDA 510(k) Submission Details - K964672

510(k) Number K964672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date February 07, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
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 1066
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K964672.
VASOVIEW BALLOON DISSECTION SYSTEM
K964171 · Origin Medsystems, Inc. · Feb 1997
TROCAR CANNULA
K963115 · United States Surgical, A Division of Tyco Healthc · Feb 1997
TANDEMRX
K970054 · Boston Scientific Corp · Feb 1997
SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
K970056 · Woodbine Optical Corp. · Jan 1997
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781
K964258 · Richard Wolf Medical Instruments Corp. · Jan 1997
NON-SHIELDED SURGICAL TROCAR AND SLEEVE
K963760 · Ethicon Endo-Surgery, Inc. · Jan 1997