Pharma-Plast Rectal Tip
FDA 510(k) K843477 · Zimmar Consulting , Ltd.
510(k) numberK843477
Submission
- Device name
- Pharma-Plast Rectal Tip
- Applicant
- Zimmar Consulting , Ltd.
Walker, MI, US - Received
- September 6, 1984
- Decision date
- December 5, 1984
- 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
Other 510(k)s with product code FCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | Intl. Medical, Inc. | 01/10/1992SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | Endovations | 08/07/1991SE |
More from Endovations
| 510(k) | Device | Decision |
|---|---|---|
| K860322 | Cliniset Infusion SetFPA · Traditional | 04/07/1986SE |
| K843478 | Pharma-Plast Uridrop-UridomeKNX · Traditional | 12/05/1984SE |
| K843468 | Pharma-Plast Suction Set Type YankauerGEA · Traditional | 11/23/1984SE |
| K843469 | Pharma-Plast Suction Tip, Type Orthopae-JOL · Traditional | 11/19/1984SE |
| K843467 | Pharma-Plast Nasal Oxygen CannulaCAT · Traditional | 11/19/1984SE |
| K843466 | Pharma-Plast Oxygen CatheterBZB · Traditional | 11/19/1984SE |
| K843470 | Pharma-Plast Connecting Tube Type Suct-BYY · Traditional | 11/16/1984SE |
| K843475 | Pharma-Plast Single Use OvershoesFXP · Traditional | 10/31/1984SE |
| K843473 | Pharma-Plast Insulin SyringeFMF · Traditional | 10/31/1984SE |
| K843472 | Pharma-Plast Syringe with NeedleFMF · Traditional | 10/31/1984SE |
Questions and answers
When was Pharma-Plast Rectal Tip cleared by the FDA?
Pharma-Plast Rectal Tip (K843477) received a 510(k) decision of Substantially Equivalent on December 5, 1984, 90 days after the submission was received.
What is the product code of K843477?
The FDA product code is FCF – Instrument, Biopsy, Mechanical, Gastrointestinal, a Class II (moderate risk) device regulated under 21 CFR 876.1075.