Cleared Traditional

AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS

K121426 · Synergetics, Inc. · General & Plastic Surgery

Jul 2012

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K121426 is an FDA 510(k) clearance for the AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on July 10, 2012, 57 days after receiving the submission on May 14, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K121426 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2012
Decision Date	July 10, 2012
Days to Decision	57 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
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).