Cleared Traditional

STANDARD ENDOSCOPE

K972056 · Laser Optik Systeme GmbH & Co. KG · General & Plastic Surgery

Jul 1997

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K972056 is an FDA 510(k) clearance for the STANDARD ENDOSCOPE, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Laser Optik Systeme GmbH & Co. KG (Mainz, DE). The FDA issued a Cleared decision on July 30, 1997, 58 days after receiving the submission on June 2, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K972056 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1997
Decision Date	July 30, 1997
Days to Decision	58 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).