Cleared Special

PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK

K061975 · Acmi Corporation · General & Plastic Surgery

Aug 2006

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K061975 is an FDA 510(k) clearance for the PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on August 10, 2006, 28 days after receiving the submission on July 13, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K061975 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2006
Decision Date	August 10, 2006
Days to Decision	28 days
Submission Type	Special
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).