Skip to content

AquaBeam Scope SC2000

by PROCEPT BioRobotics Corporation

AquaBeam Scope SC2000 (SC2000-A) is a Class II device made by PROCEPT BioRobotics Corporation, cleared under FDA 510(k) K212835 on 6 Oct 2021, granted FDA De Novo DEN170024 on 21 Dec 2017 and listed in FDA GUDID since 28 Mar 2019 (UDI-DI B614SC20001), active as of 23 Oct 2026.

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

510(k) De Novo

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK212835 Date6 Oct 2021DecidedStatusActive
United StatesGUDID listing NumberB614SC20001 UDI-DI Date28 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN170024 Date21 Dec 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K212835 decided 6 Oct 2021 Active
  • FDA De Novo DEN170024 decided 21 Dec 2017 Active
  • FDA GUDID UDI-DI B614SC20001 listed 28 Mar 2019 Listed

Timeline

3 dated events

  1. Granted FDA De Novo DEN170024
  2. Listed FDA GUDID B614SC20001
  3. Cleared FDA 510(k) K212835

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo, FDA 510(k) Active

Specification

GUDID

Trade name
AquaBeam Scope
Generic name
Rigid endoscope telescope
Model / Ref / Catalog
SC2000, SC2000-A
Primary DI / UDI-DI
B614SC20001
510(k) Number
De Novo Number
FDA product code
PZP
GMDN term
Rigid endoscope telescope
Device class
Class II
Regulation number
876.4350
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Rigid endoscope telescope

Cleared under the same submission (DEN170024)

and 2 more cleared under DEN170024

Cleared under the same submission (K212835)

Similar devices in this category

Other devices filed under Rigid endoscope telescope.

Other devices from PROCEPT BioRobotics Corporation

See all devices from PROCEPT BioRobotics Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)