Pristine Surgical
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Pristine Surgical is a medical device manufacturer, with 6 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) as of 14 Nov 2026.
- Devices
- 6
Registry facts
- Registries
- FDA 510(k) 3
- FDA GUDID 3
- Device classes
- FDA Class II 5
- FDA Class I 1
What Pristine Surgical makes
Pristine Surgical manufactures rigid optical arthroscopes, including single-use models, and related arthroscopic visualization systems such as the Summit Imagine Processing Unit, Summit Hi-Flow Cannula, Summit Single Use Surgical Arthroscope, Pristine Arthroscopic Visualization System, and Pristine Scope.
The company's portfolio includes Class I and Class II devices, which are listed in the FDA 510(k) and FDA UDI registries.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Pristine Arthroscopic Visualization System Ref K223244
Regimes: 510(k) Registry: 510(k)Pristine Scope Ref K193161
Regimes: 510(k) Registry: 510(k)Pristine Scope Ref K183165
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pristine Surgical have in the registry?
The registry currently lists 6 devices for Pristine Surgical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pristine Surgical's devices?
Among its 6 most recently registered devices, Pristine Surgical has devices listed in FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Pristine Surgical's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Pristine Surgical's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pristine Surgical in the registry?
The most recently registered devices listed for Pristine Surgical include Summit Imagine Processing Unit PS-IPU001, Summit Hi-Flow Cannula PS-CAN001, Summit Single Use Surgical Arthroscope PS-ART001 and Pristine Arthroscopic Visualization System.