Oval Cup Hot Biopsy Forcep (Model C-52)
FDA 510(k) K874009 · Endovations
510(k) numberK874009
Submission
- Device name
- Oval Cup Hot Biopsy Forcep (Model C-52)
- Applicant
- Endovations
Camp Hill, PA, US - Received
- October 1, 1987
- Decision date
- December 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
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More from Endochoice, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955413 | Endovations Triple Lumen Balloon Dilatation CatheterFGE · Traditional | 02/08/1996SE |
| K942110 | Inject-SnareFDI · Traditional | 10/13/1994SE |
| K944049 | Oxygen MouthguardMNK · Traditional | 10/11/1994SE |
| K934315 | Endovations(R) .035 Pre-Cut PapillatomeKNS · Traditional | 02/28/1994SE |
| K913841 | 2 Lumen Endos Retro Cholangiopancrea Injec CathFGE · Traditional | 10/08/1991SE |
| K913870 | 5MM MicroscissorsGCJ · Traditional | 09/16/1991SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | 08/07/1991SE |
| K892218 | Endo-SpongeMNL · Traditional | 05/31/1989SE |
| K883093 | Transendoscopic Aspiration NeedleFBK · Traditional | 12/08/1988SE |
| K873360 | Enteron Percutan. Endoscopic Gastrostomy Tray-PegKNT · Traditional | 03/30/1988SE |
Questions and answers
When was Oval Cup Hot Biopsy Forcep (Model C-52) cleared by the FDA?
Oval Cup Hot Biopsy Forcep (Model C-52) (K874009) received a 510(k) decision of Substantially Equivalent on December 29, 1987, 89 days after the submission was received.
What is the product code of K874009?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.