Cleared Traditional

K990547 - PILLING WECK SURGICAL Y STENT FORCEPS
(FDA 510(k) Clearance)

K990547 · Pilling Weck, Inc. · Ear, Nose, Throat

Apr 1999

Decision

64d

Days

Class 2

Risk

K990547 is an FDA 510(k) clearance for the PILLING WECK SURGICAL Y STENT FORCEPS. This device is classified as a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ).

Submitted by Pilling Weck, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on April 27, 1999, 64 days after receiving the submission on February 22, 1999.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..

Submission Details

510(k) Number	K990547 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 1999
Decision Date	April 27, 1999
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).