Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008004502

FEI Number

3008004502

Entity Name

HISTOLOGICS LLC

City/State/Country

Anaheim, CA, US

Establishment Address

4095 E La Palma Ave Ste N, Anaheim, CA 92807, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Histologics LLC (Owner Number: 10030673)

Owner / Operator Contact Address

1715 Countryside Drive, Millcreek, UT 84106, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SpiraBrush ® Clip Surgical OB Guide SFT-2100 Soft-ECC-S ® Tissue Collection and Transport System SFT-1500 SoftBiopsy ®-TZ Tissue Collection and Transport System SFT-4500 Soft K-Rette ® Tissue Collection and Transport System SFT-1000 SoftBiopsy ® Tissue Collection and Transport System SFT-3000 SoftBiopsy ® - AG Tissue Collection and Transport System SFT-5100 Sweep Biopsy Tissue Collection and Transport System SFT-4100 Soft K Bride ® Tissue Collection and Transport System SFT-2000 Soft-ECC ® Tissue Collection and Transport System Soft K-Cot ® Soft K-Rette ® Soft-Biopsy ®-AG Sweep Biopsy Soft -Biopsy ®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2009-10-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-03-01
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2014-02-03
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-07-05

Official Correspondent

Nathaniel Henriod

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Histologics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008004502. Last updated year: 2026. Please use registration number 3008004502 when referencing this establishment in official correspondence.