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Prager Shell

by Esi, Inc.

510(k) K082893

Prager Shell is a Class II device made by Esi, Inc., cleared under FDA 510(k) K082893 on 5 Dec 2008, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082893 Date5 Dec 2008ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ITX
Device class
Class II
Regulation
21 CFR Part 892.1570
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K082893

19 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K082893
UDI-DISize and differences
Prager Shell® P-100
Esi, Inc.
P-100 / P-100B360P1000
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-100-AS
Esi, Inc.
P-100-AS / P-100-ASB360P100AS0
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-101
Esi, Inc.
P-101 / P-101B360P1010
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-101-2
Esi, Inc.
P-101-2 / P-101-2B360P10120
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-102
Esi, Inc.
P-102 / P-102B360P1020
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-102-2
Esi, Inc.
P-102-2 / P-102-2B360P10220
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-103
Esi, Inc.
P-103 / P-103B360P1030
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-103GS
Esi, Inc.
P-103GS / P-103GSB360P103GS0
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-103SV
Esi, Inc.
P-103SV / P-103SVB360P103SV0
Outer Diameter 14 mm; Lumen/Inner Diameter 12.2 mm
On the market
Prager Shell® P-104
Esi, Inc.
P-104 / P-104B360P1040
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-104GS
Esi, Inc.
P-104GS / P-104GSB360P104GS0
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-104SV
Esi, Inc.
P-104SV / P-104SVB360P104SV0
Outer Diameter 14 mm; Lumen/Inner Diameter 12.2 mm
On the market
Prager Shell® P-105
Esi, Inc.
P-105 / P-105B360P1050
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-106
Esi, Inc.
P-106 / P-106B360P1060
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-106GS
Esi, Inc.
P-106GS / P-106GSB360P106GS0
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-106SV
Esi, Inc.
P-106SV / P-106SVB360P106SV0
Outer Diameter 14 mm; Lumen/Inner Diameter 12.2 mm
On the market
Prager Shell® P-107-2
Esi, Inc.
P-107-2 / P-107-2B360P10720
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
Prager Shell® P-110RXP
Esi, Inc.
P-110RXP / P-110RXPB360P110RXP0
Outer Diameter 15.7 mm; Lumen/Inner Diameter 14 mm
On the market
PRAGER SHELL® P106SVGS P106SV GOLD SERIES
Esi, Inc.
P106SV GOLD SERIESB360PSVGS0
Lumen/Inner Diameter 12.2 mm; Outer Diameter 14 mm
On the market

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

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