Cleared Traditional

ZEISS ENDOLIVE STERO ENDOSCOPE

K950985 · Carl Zeiss, Inc. · General & Plastic Surgery

Mar 1995

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K950985 is an FDA 510(k) clearance for the ZEISS ENDOLIVE STERO ENDOSCOPE, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on March 29, 1995, 26 days after receiving the submission on March 3, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K950985 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 1995
Decision Date	March 29, 1995
Days to Decision	26 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

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).