# K964561: Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable Tips, 56FR, TA

- Pathway: 510(k) (Traditional)
- Applicant: Bioenterics Corp.
- Decided: Feb 11, 1997 after 90 days
- Product code: FDG (Retractor, Fiberoptic)
- Device class: 1
- Regulation: 21 CFR 876.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ENDOLUMINA® I Illuminated Bougie: named in the summary without a submission number

## Most influential descendants
- K991323: Smith & Nephew Subcutaneous Illuminator (1999), 2 descendants of its own
- K032387: Trivex System (2003), 1 descendant of its own
- K212894: PhasTIPP (2022), 0 descendants of its own

## Indications for use
The ENDOLUMINA II Transillumination System (EIB II) is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures.

Source page: https://510kreport.com/device/K964561
Methodology: https://510kreport.com/methodology