Pharma-Plast Rectal Tip
by Zimmar Consulting, Ltd. 510(k)
Active
510(k) K843477
Overview
The Pharma-Plast Rectal Tip is a mechanical gastrointestinal instrument used for biopsy procedures. It is classified under product code FCF and is intended for use in gastroenterology and urology.
This device is supplied as a single-use instrument and is not MRI safe. It is stored at room temperature and has FDA 510(k) clearance with number K843477, granted on December 5, 1984, as substantially equivalent to predicate devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843477 | Date5 Dec 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FCF
- FDA applicant
- Zimmar Consulting , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zimmar Consulting, Ltd.
Questions
What clinical procedures is the Pharma-Plast Rectal Tip designed for?
It is intended for biopsy procedures within the gastrointestinal tract, serving both gastroenterology and urology specialties. The design allows clinicians to obtain tissue samples safely during endoscopic examinations.
How is the device supplied and what are the sterility considerations?
The Rectal Tip is provided as a single‑use, sterile instrument. Because it is disposable, it eliminates the need for re‑processing, reducing cross‑contamination risk and ensuring consistent performance for each procedure.
Can the Pharma-Plast Rectal Tip be used in an MRI environment?
No, the device is not MRI safe. Its materials or construction could be affected by the magnetic field, potentially causing device malfunction or patient safety issues, so it must be removed before any MRI scanning.
What are the storage requirements for this instrument?
The instrument should be stored at room temperature, which simplifies inventory management and eliminates the need for refrigeration or special climate control.
What regulatory pathway did the Pharma-Plast Rectal Tip follow?
It received FDA 510(k) clearance (K843477) on December 5, 1984, through the traditional clearance route, demonstrating substantial equivalence to previously cleared predicate devices under product code FCF.