Pristine Surgical LLC

Palm Harbor, FL, US

PRISTINE SURGICAL LLC appears in FDA device records in Palm Harbor, FL. FDA records list 3 510(k) clearances between 2019-01-16 and 2022-12-21, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Pristine Surgical LLC between 2019 and 2022. The busiest year on record is 2019, with 1. The most recent is 2022, with 1.

Clearances by year, as a table

510(k) clearance decisions for Pristine Surgical LLC, by decision year
Year	Clearances
2019	1
2020	1
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K223244	Pristine Arthroscopic Visualization System	HRX	Substantially Equivalent	2022-12-21
K193161	Pristine Scope	GCJ	Substantially Equivalent	2020-04-21
K183165	Pristine Scope	HRX	Substantially Equivalent	2019-01-16

Registered establishments

FDA registered establishments for Pristine Surgical LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3019766696	3019766696	PRISTINE SURGICAL LLC	34125 Us Hwy 19 N Ste 200, Palm Harbor, FL 34684 US	2026	HRX NBH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain