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Summit Imagine Processing Unit PS-IPU001

by Pristine Surgical

Summit Imagine Processing Unit PS-IPU001 is a Class II device made by Pristine Surgical, cleared under FDA 510(k) K223244 on 21 Dec 2022 and listed in FDA GUDID since 20 May 2024 (UDI-DI 00860003634615), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K223244

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860003634615 UDI-DI Date20 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK223244 Date21 Dec 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223244 decided 21 Dec 2022 Active
  • FDA GUDID UDI-DI 00860003634615 listed 20 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223244
  2. Listed FDA GUDID 00860003634615

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Summit Imagine Processing Unit
Generic name
Rigid optical arthroscope, single-use
Model / reference
PS-IPU001
Primary DI / UDI-DI
00860003634615
510(k) Number
FDA product code
HRX
GMDN term
Rigid optical arthroscope, single-use
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid optical arthroscope, single-use

Similar devices

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

Other devices from Pristine Surgical

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (9, all answered No)