ESIClass III

Polymer, Natural-Absorbable Gelatin Material

Unknown

ESI is the FDA product code for Polymer, Natural-Absorbable Gelatin Material, a class III device type. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1996-04-25, and no recalls.

Classification record

Product code: ESI
Device name: Polymer, Natural-Absorbable Gelatin Material
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code ESI

By decision year

2 clearances under product code ESI with a decision year between 1991 and 1996, 1991 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code ESI by decision year
Year	Clearances
1991	1
1996	1

Applicants with the most clearances

Product code ESI

Applicants holding the most 510(k) clearances under product code ESI
Applicant	Clearances
Leisegang Medical, Inc.	1
Patrick C. Jacobssen	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code ESI.

Recent clearances

Product code ESI

Recent recalls

Product code ESI

FDA records show no recalls under product code ESI.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)