Cleared Traditional

K951387 - SYMBIOSIS BIPOLAR SCISSORS
(FDA 510(k) Clearance)

K951387 · Symbiosis Corp. · General & Plastic Surgery

Apr 1995

Decision

14d

Days

Class 2

Risk

K951387 is an FDA 510(k) clearance for the SYMBIOSIS BIPOLAR SCISSORS. This device is classified as a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ).

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on April 10, 1995, 14 days after receiving the submission on March 27, 1995.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. 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)..

Submission Details

510(k) Number	K951387 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 1995
Decision Date	April 10, 1995
Days to Decision	14 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).