Cleared Traditional

QUICK SWITCH LAPAROSCOPIC INSTRUMENTS

K932648 · Microline Pentax, Inc. · General & Plastic Surgery

Oct 1993

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K932648 is an FDA 510(k) clearance for the QUICK SWITCH LAPAROSCOPIC INSTRUMENTS, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Microline Pentax, Inc. (Devers, US). The FDA issued a Cleared decision on October 12, 1993, 132 days after receiving the submission on June 2, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K932648 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1993
Decision Date	October 12, 1993
Days to Decision	132 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).