Pilling Weck Surgical Y Stent Forceps
FDA 510(k) K990547 · Pilling Weck, Inc.
510(k) numberK990547
Submission
- Device name
- Pilling Weck Surgical Y Stent Forceps
- Applicant
- Pilling Weck, Inc.
Research Triangle Park, NC, US - Received
- February 22, 1999
- Decision date
- April 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
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…
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Questions and answers
When was Pilling Weck Surgical Y Stent Forceps cleared by the FDA?
Pilling Weck Surgical Y Stent Forceps (K990547) received a 510(k) decision of Substantially Equivalent on April 27, 1999, 64 days after the submission was received.
What is the product code of K990547?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.