Pristine Arthroscopic Visualization System
Pristine Surgical
PRISTINE SURGICAL LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3019766696 | 3019766696 | PRISTINE SURGICAL LLC | 1 | N | 2026-01-01 | 34125 Us Hwy 19 N Ste 200 Palm Harbor FL US 34684 |
| 3011572298 | 3011572298 | PRISTINE DENTAL & MEDICAL SUPPLIES | 1 | Y | 2020-04-25 | 14946 Shoemaker Ave Ste E Santa Fe Springs CA US 90670 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 318933 | 1656453618 | K223244 | Pristine Arthroscopic Visualization System | HRX | 2022-12-21 |
| 318933 | 1490752905 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HRX | 1 | 2022-12-21 |
PMN#
Pristine Scope
Pristine Surgical
Pristine Hemodialysis Catheter
Pristine Access Technologies Ltd.
Pristine Scope
Pristine Surgical
GUDID#
Summit Hi-Flow Cannula - PS-CAN001
2025-09-05
Summit Hi-Flow Cannula - PS-CAN001
2025-09-05
Summit Single Use Surgical Arthroscope - PS-ART001
2024-05-20
Summit Imagine Processing Unit - PS-IPU001
2024-05-20
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