Pelvic Exam Tray
by Medcare Custom Packaging, Inc.
510(k) K934732
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934732 | Date30 Dec 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HHT
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Pelvic Exam Tray is a Spatula, Cervical, Cytological (per FDA classification HHT), designed to support gynecological examinations. It is intended for use in obstetrics and gynecology procedures, providing a sterile, organized setup for collecting cytological samples or performing minor pelvic examinations. The tray is structured to hold necessary instruments and supplies in a single, accessible configuration.
This device is supplied as a single-use, non-sterile tray (unless sterilized by the facility) and is classified under 21 CFR 884.4530 for obstetrics/gynecology applications. It is intended for use in clinical settings such as hospitals or outpatient care facilities. The tray’s design aligns with FDA 510(k) clearance (K934732) under the Obstetrics/Gynecology advisory committee, with no noted MRI safety restrictions. Storage should follow standard medical tray protocols to maintain integrity until use.
Other devices from Medcare Custom Packaging, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Pelvic Exam Tray used for?
The Pelvic Exam Tray is a cervical spatula tray intended for gynecological examinations. It supports obstetrics and gynecology procedures by providing a sterile, organized setup for collecting cytological samples or performing minor pelvic exams. The tray’s design ensures easy access to essential instruments and supplies during clinical procedures.
Is the Pelvic Exam Tray single-use or reusable?
The Pelvic Exam Tray is supplied as a single-use device. While it is initially non-sterile, facilities may choose to sterilize it before use if required by their protocols. This aligns with standard medical practice for maintaining hygiene and preventing cross-contamination in clinical settings.
How should the Pelvic Exam Tray be stored?
Storage of the Pelvic Exam Tray should follow standard medical tray protocols to preserve its integrity until use. Ensure the tray is kept in a clean, dry environment, protected from moisture, dust, or physical damage. Proper storage helps maintain the tray’s functionality and readiness for clinical procedures.
Does the Pelvic Exam Tray have any MRI safety restrictions?
No MRI safety restrictions are noted for the Pelvic Exam Tray. This means the device can be safely used in environments where MRI procedures are performed without interference or risk. Always verify with facility protocols to ensure compatibility with other equipment.
What regulatory pathway does the Pelvic Exam Tray follow?
The Pelvic Exam Tray follows the FDA 510(k) clearance pathway, specifically under the Obstetrics/Gynecology advisory committee. It was granted clearance as substantially equivalent (SE) to a predicate device under the classification HHT (Spatula, Cervical, Cytological) and is regulated under 21 CFR 884.4530 for obstetrics/gynecology applications.