# K964112: Berenstein Coil

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Feb 26, 1997 after 134 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- 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 K961923 (1996). 1 ancestor in all.
202 later devices descend from it; 2 cite it directly.
2 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961923: Berenstein Coil, Target Therapeutics (1996) Summary page 1.
- (no number) Target Therapeutics occlusion coils: named in the summary without a submission number

## Most influential descendants
- K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce (1997), 150 descendants of its own
- K991139: Guglielmi Detachable (GDC) (1999), 138 descendants of its own
- K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1 (2000), 105 descendants of its own
- K022420: Micrus Stretch-Resistant Microcoil System, MSR01 (2002), 103 descendants of its own
- K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC) (2000), 98 descendants of its own

## Indications for use
Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.

Source page: https://510kreport.com/device/K964112
Methodology: https://510kreport.com/methodology