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Pristine Arthroscopic Visualization System

by Pristine Surgical

510(k) K223244

Pristine Arthroscopic Visualization System is a Class II device made by Pristine Surgical, cleared under FDA 510(k) K223244 on 21 Dec 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK223244 Date21 Dec 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Devices cleared under K223244

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K223244
UDI-DISize and differences
Summit Imagine Processing Unit PS-IPU001
Pristine Surgical
PS-IPU00100860003634615 —On the market
Summit Single Use Surgical Arthroscope PS-ART001
Pristine Surgical
PS-ART00110860003634605 —No longer on the market

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from Pristine Surgical