# Esi, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Esi, Inc. is a medical device manufacturer, with 26 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/esi-inc>
- Also registered as: Esi
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer
- Registrations: FDA
- FDA FEI: 3004181533

## Figures

- Devices: 26
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 23, FDA 510(k) 3
- Device classes: FDA Class II 24, FDA Class I 2

## Devices

The first 26 of 26, in the order of the canonical page, which lists them all.

- [Prager Shell® P-103GS](https://devicerts.com/devices/prager-shell-r-p-103gs) · Class II · GUDID · status: Active
- [Prager Shell® P106SVGS P106SV Gold Series](https://devicerts.com/devices/prager-shell-r-p106svgs-p106sv-gold-series) · Class II · GUDID · status: Active
- [Prager Shell® P-106](https://devicerts.com/devices/prager-shell-r-p-106) · Class II · GUDID · status: Active
- [Kera-Flow KF100](https://devicerts.com/devices/kera-flow-kf100) · Class I · GUDID · status: Listed
- [Prager Shell® P-104SV](https://devicerts.com/devices/prager-shell-r-p-104sv) · Class II · GUDID · status: Active
- [Prager Ext Set A1236 011B1236](https://devicerts.com/devices/prager-ext-set-a1236-011b1236) · Class II · GUDID · status: Active · open recall
- [Prager Ext Set B1263 011B1263](https://devicerts.com/devices/prager-ext-set-b1263-011b1263) · Class II · GUDID · status: Active · open recall
- [Prager Shell® P-103](https://devicerts.com/devices/prager-shell-r-p-103) · Class II · GUDID · status: Active
- [Prager Shell® P-104](https://devicerts.com/devices/prager-shell-r-p-104) · Class II · GUDID · status: Active
- [Prager Shell® P-102-2](https://devicerts.com/devices/prager-shell-r-p-102-2) · Class II · GUDID · status: Active
- [Prager Shell® P-110RXP](https://devicerts.com/devices/prager-shell-r-p-110rxp) · Class II · GUDID · status: Active
- [Prager Shell® P-102](https://devicerts.com/devices/prager-shell-r-p-102) · Class II · GUDID · status: Active
- [Prager Shell® P-105](https://devicerts.com/devices/prager-shell-r-p-105) · Class II · GUDID · status: Active
- [Prager Shell® P-100-AS](https://devicerts.com/devices/prager-shell-r-p-100-as) · Class II · GUDID · status: Active
- [ClearScan® CS200](https://devicerts.com/devices/clearscan-r-cs200) · Class II · GUDID · status: Active
- [Prager Shell® P-101](https://devicerts.com/devices/prager-shell-r-p-101) · Class II · GUDID · status: Active
- [Prager Shell® P-104GS](https://devicerts.com/devices/prager-shell-r-p-104gs) · Class II · GUDID · status: Active
- [Prager Shell® P-106GS](https://devicerts.com/devices/prager-shell-r-p-106gs) · Class II · GUDID · status: Active
- [Prager Shell® P-107-2](https://devicerts.com/devices/prager-shell-r-p-107-2) · Class II · GUDID · status: Active
- [Prager Shell® P-103SV](https://devicerts.com/devices/prager-shell-r-p-103sv) · Class II · GUDID · status: Active
- [Prager Shell® P-106SV](https://devicerts.com/devices/prager-shell-r-p-106sv) · Class II · GUDID · status: Active
- [Prager Shell® P-100](https://devicerts.com/devices/prager-shell-r-p-100) · Class II · GUDID · status: Active
- [Prager Shell® P-101-2](https://devicerts.com/devices/prager-shell-r-p-101-2) · Class II · GUDID · status: Active
- [Clearscan](https://devicerts.com/devices/clearscan-itx) · ref K080119 · Class II · 510(k) · status: Active · decision 2008-02-21
- [Afterloading Gynecological Applicator](https://devicerts.com/devices/afterloading-gynecological-applicator-iwj) · ref K813230 · Class I · 510(k) · status: Active · decision 1981-12-29
- [Prager Shell](https://devicerts.com/devices/prager-shell-itx) · ref K082893 · Class II · 510(k) · status: Active · decision 2008-12-05

## Source and citation

- Cite as: Esi, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/esi-inc (data as of 2026-11-14).
- Data sources: [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/esi-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/esi-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.