Cleared Traditional

MAJOR SET-UP TRAY

K912159 · Medical Device Inspection Co., Inc. · General & Plastic Surgery

Aug 1991

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K912159 is an FDA 510(k) clearance for the MAJOR SET-UP TRAY, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on August 29, 1991, 105 days after receiving the submission on May 16, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K912159 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 1991
Decision Date	August 29, 1991
Days to Decision	105 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).