Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019766696

FEI Number

3019766696

Entity Name

PRISTINE SURGICAL LLC

City/State/Country

Palm Harbor, FL, US

Establishment Address

34125 Us Hwy 19 N Ste 200, Palm Harbor, FL 34684, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Pristine Surgical LLC (Owner Number: 10088394)

Owner / Operator Contact Address

34125 US Highway 19N Ste 200, Palm Harbor, FL 34684, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223244

PMA Number

N/A

All Registered Proprietary Names

Summit High-Flow Cannula Pristine Arthroscopic Visualization System Summit Single Use Arthroscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2025-02-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-07-13

Official Correspondent

Jeremy Moore

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pristine Surgical LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3017450165	NANICE MEDICAL SOLUTIONS, LLC	Flourtown, PA, US
1526711	ISOMEDIX OPERATIONS INC	GROVEPORT, OH, US
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US
3010011359	BIORAD MEDISYS PVT. LTD.	Pune Maharashtra, IN
9611278	Stengelin Medical GmbH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019766696. Last updated year: 2026. Please use registration number 3019766696 when referencing this establishment in official correspondence.