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Aesculap Slim Clip Applier Forceps

K173271 Class II Special
Decision Date
2017-11-10
Sponsor / Applicant
Aesculap, Inc.

Technical Specification

510(k) Submission ID K173271
Product Code HCI
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.4175
Decision Date 2017-11-10
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Aesculap Slim Clip Applier Forceps received FDA 510(k) clearance under submission number K173271, sponsored by Aesculap, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-11-10.

Classification & Regulation

This clearance is catalogued under FDA product code HCI and 21 CFR 882.4175, within the Neurology review panel as a Class II device.