# K972506: Infinitech Bullet Endo Illuminated Pick Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: Infinitech, Inc.
- Decided: Oct 1, 1997 after 90 days
- Product code: HJM (Transilluminator, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1945
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940392 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940393: Peregrine Wide Angle Light Pipe, Peregrine Surgical, Ltd. (1994) Summary page 1.
- K940392: Peregrine Pic Minipulator, Peregrine Surgical, Ltd. (1994) Summary page 1.

## Indications for use
The Pick Manipulator is a manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination. There are no contraindications for the device.

Source page: https://510kreport.com/device/K972506
Methodology: https://510kreport.com/methodology