# K972353: Erco-Ribbon

- Pathway: 510(k) (Traditional)
- Applicant: Ercons, Inc.
- Decided: Oct 28, 1997 after 126 days
- Product code: LKY (Device, External Penile Rigidity)
- Device class: 2
- Regulation: 21 CFR 876.5020
- 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 K841257 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841257: Sta-Potent System, Nu-Potent (1984) Summary page 1.
- K844445: Revive System, Revive Systems Corp. (1985) Summary page 1.
- K891125: Constrictor Ring for Penile Erection, Performance, Inc. (1989) Summary page 1.
- K901223: Vacuum Erection Device (Ved), Mission Pharmacal Co. (1990) Summary page 1.
- K902240: Vet (Vacuum Erection Technology), Vetco, Inc. (1990) Summary page 1.
- K960828: Pos-T-Vac B-10 Band Kit, Pos-T-Vac, Inc. (1996) Summary page 1.

## Indications for use
Erco-Ribbon™ is used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump or naturally). Erco-Ribbon can be used for patients with following conditions: a) separately: premature ejaculation firm but short lasting erection b) as a part of a vacuum constriction system Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Radiation therapy Spinal cord injury

Source page: https://510kreport.com/device/K972353
Methodology: https://510kreport.com/methodology