Cleared Traditional

K980123 - CARTER-THOMASON NEEDLE-POINT SUTURE PAS...

K980123 is the FDA 510(k) clearance for CARTER-THOMASON NEEDLE-POINT SUTURE PAS... by Louisville Laboratories, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K980123 · Louisville Laboratories, Inc. · General & Plastic Surgery device
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Mar 1998
Decision
54d
Days
Class 2
Risk

K980123 is an FDA 510(k) clearance for the CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (Louisville, US). The FDA issued a Cleared decision on March 9, 1998 after a review of 54 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 Louisville Laboratories, Inc. devices

Submission Details

510(k) Number K980123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1998
Decision Date March 09, 1998
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 678
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K980123.
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
K980079 · Lumenis, Inc. · Apr 1998
ENDOPATH AND PROXIMATE LINEAR CUTTERS
K980023 · Ethicon Endo-Surgery, Inc. · Mar 1998
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K980022 · Ethicon Endo-Surgery, Inc. · Mar 1998
KSEA ENDOTIP SYSTEM
K973909 · KARL STORZ Endoscopy-America, Inc. · Feb 1998
MENTOR SKIN PROTECTION PAD
K980050 · Mentor Corp. · Feb 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · Smith & Nephew, Inc. · Jan 1998