Amcath Disposable Biopsy Forceps
FDA 510(k) K915142 · Intl. Medical, Inc.
510(k) numberK915142
Submission
- Device name
- Amcath Disposable Biopsy Forceps
- Applicant
- Intl. Medical, Inc.
Danielson, CT, US - Received
- November 14, 1991
- Decision date
- January 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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|---|---|---|---|
| K070759 | Powered Ez-Io Pediatric Bone Marrow Aspiration SystemFCF · Traditional | Vidacare Corporation | 05/21/2007SE |
| K062833 | Powered Ez-Io Bone Marrow Aspiration SystemFCF · Traditional | Vidacare Corporation | 11/30/2006SE |
| K984168 | Barrett's Esophageal Cytology DeviceFCF · Traditional | United States Endoscopy Group, Inc. | 12/07/1999SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | Endovations | 08/07/1991SE |
| K843477 | Pharma-Plast Rectal TipFCF · Traditional | Zimmar Consulting , Ltd. | 12/05/1984SE |
More from Zimmar Consulting , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K970507 | Peak Flow MeterBZH · Traditional | 06/13/1997SE |
| K943078 | Hot Biopsy ForcepsKGE · Traditional | 11/14/1994SE |
| K940370 | American Catheter E.R.C.P. CannulaFGE · Traditional | 08/17/1994SE |
| K940335 | American Catheter Poly-SnareFDI · Traditional | 07/21/1994SE |
| K942068 | American Catheter SphincterotomeKNS · Traditional | 06/24/1994SE |
| K930410 | Durham; Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
| K930406 | Durham; Min Bore Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
| K923200 | Amcath Disposable Cytology BrushFDX · Traditional | 12/07/1992SE |
| K912927 | Amcath Disposable Trocar and Trocar SleeveGCJ · Traditional | 09/19/1991SE |
| K912605 | Amcath Disposable Micro ScissorsGCJ · Traditional | 07/11/1991SE |
Questions and answers
When was Amcath Disposable Biopsy Forceps cleared by the FDA?
Amcath Disposable Biopsy Forceps (K915142) received a 510(k) decision of Substantially Equivalent on January 10, 1992, 57 days after the submission was received.
What is the product code of K915142?
The FDA product code is FCF – Instrument, Biopsy, Mechanical, Gastrointestinal, a Class II (moderate risk) device regulated under 21 CFR 876.1075.