Cleared Traditional

SELECTA-TIP LAPAROSCOPIC SCISSORS

K970826 · Microline Pentax, Inc. · General & Plastic Surgery

Mar 1997

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K970826 is an FDA 510(k) clearance for the SELECTA-TIP LAPAROSCOPIC SCISSORS, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Microline Pentax, Inc. (Beverly, US). The FDA issued a Cleared decision on March 28, 1997, 22 days after receiving the submission on March 6, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K970826 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 1997
Decision Date	March 28, 1997
Days to Decision	22 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).