Cleared Traditional

CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET

K980123 · Louisville Laboratories, Inc. · General & Plastic Surgery

Mar 1998

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K980123 is an FDA 510(k) clearance for the CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Louisville Laboratories, Inc. (Louisville, US). The FDA issued a Cleared decision on March 9, 1998, 54 days after receiving the submission on January 14, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K980123 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — 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).