# K961923: Berenstein Coil

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Aug 15, 1996 after 90 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
203 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)
- None. The FDA summary names its predicate without a number.
- (no number) Target Therapeutics Platinum Occlusion Coils: named in the summary without a submission number
- (no number) Cook Embolization Coils: named in the summary without a submission number

## Most influential descendants
- K964112: Berenstein Coil (1997), 202 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K961923
Methodology: https://510kreport.com/methodology