Oval Cup Biopsy Forcep
FDA 510(k) K911155 · Endovations
510(k) numberK911155
Submission
- Device name
- Oval Cup Biopsy Forcep
- Applicant
- Endovations
Mechanicsburg, PA, US - Received
- March 15, 1991
- Decision date
- August 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCF – Instrument, Biopsy, Mechanical, Gastrointestinal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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| K984168 | Barrett's Esophageal Cytology DeviceFCF · Traditional | United States Endoscopy Group, Inc. | 12/07/1999SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | Intl. Medical, Inc. | 01/10/1992SE |
| K843477 | Pharma-Plast Rectal TipFCF · Traditional | Zimmar Consulting , Ltd. | 12/05/1984SE |
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| K883093 | Transendoscopic Aspiration NeedleFBK · Traditional | 12/08/1988SE |
| K873360 | Enteron Percutan. Endoscopic Gastrostomy Tray-PegKNT · Traditional | 03/30/1988SE |
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Questions and answers
When was Oval Cup Biopsy Forcep cleared by the FDA?
Oval Cup Biopsy Forcep (K911155) received a 510(k) decision of Substantially Equivalent on August 7, 1991, 145 days after the submission was received.
What is the product code of K911155?
The FDA product code is FCF – Instrument, Biopsy, Mechanical, Gastrointestinal, a Class II (moderate risk) device regulated under 21 CFR 876.1075.