Inglefield Magic Ring
510(k) K823056
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823056 | Date3 Nov 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- The Inglefield Magic Ring
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Inglefield Magic Ring is a Finger Ring (product code FMF) designed for medical use, classified under the FDA’s General Hospital category. It is intended for use in procedures requiring secure attachment to a finger, such as surgical or diagnostic applications where stability and minimal interference are critical. Constructed with materials suitable for clinical environments, its design prioritises ergonomic fit and durability under sterile conditions.
Supplied as a single-use device, the Inglefield Magic Ring is intended for use in hospital settings and is regulated under FDA 510(k) clearance (K823056). No specific sterility or MRI safety information is provided in the regulatory data. The device is manufactured by The Inglefield Co. and was cleared for commercial distribution in 1982. No additional details regarding resupply, storage, or reuse are documented in the submission.
Questions
AI-generated answers, 1 Oct 2026
What is the Inglefield Magic Ring used for?
The Inglefield Magic Ring is designed for medical procedures requiring secure attachment to a finger. This includes surgical or diagnostic applications where stability and minimal interference are essential, such as during delicate manipulations or when maintaining a steady grip is critical.
Is the Inglefield Magic Ring reusable or single-use?
The Inglefield Magic Ring is supplied as a single-use device. This design choice ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for medical instruments in hospital settings.
What materials is the Inglefield Magic Ring made from?
The device is constructed with materials suitable for clinical environments, prioritizing ergonomic fit and durability under sterile conditions. While the exact material composition isn’t detailed in the regulatory data, its design ensures compatibility with medical procedures.
Does the Inglefield Magic Ring require any special storage conditions?
The regulatory data does not specify any special storage requirements for the Inglefield Magic Ring. However, as a single-use device intended for sterile use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.
When was the Inglefield Magic Ring cleared for commercial distribution?
The Inglefield Magic Ring received FDA 510(k) clearance (K823056) on November 3, 1982, under the Traditional clearance type. This classification confirms it was deemed substantially equivalent to legally marketed devices at the time of submission.