EnSite™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: EnSite™ FDA UDI
Generic Name: Medical table clamp FDA UDI
Device Name: Adjustable Field Frame Bracket FDA UDI
Model / Reference: ENSITE-FF-ABRKT-01 FDA UDI
Description: Adjustable Field Frame Bracket FDA UDI

Identifiers

Catalog Number: ENSITE-FF-ABRKT-01 FDA UDI
Primary DI / UDI-DI: 05415067033550 FDA UDI
510(k) Number: K202066 FDA UDI
K221213 FDA UDI
K223094 FDA UDI
K231415 FDA UDI
K242016 FDA UDI
FDA Product Code: DQK FDA UDI
GMDN Term: Medical table clamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical table clamp

EnSite™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical table clamp.

Dual Pendant Holder — Mizuho Orthopedic Systems, Inc. · Class I
Quad® Clamp — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
Side rail adapter pair — Maquet, Inc. · Class I
SPRINGLOC CLAMP JPN — Skytron, LLC · Class I
De Mayo Push Button™ Clamp — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
Radial clamp — Reison Medical AB · Class I
Secure-Release — STERIS CORPORATION · Class I
COUPLER II RADIOLUCENT DORO ADAPTER, REFURBISHED — Mizuho Orthopedic Systems, Inc. · Class I

Cleared under the same submission

K221213 also covers:

K223094 also covers:

K231415 also covers:

K242016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI 669d97bd-21c7-4a61-b8d8-deb46fe87bec 37 fields · synced May 30, 2026