# AquaBeam Scope SC2000

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/aquabeam-scope-sc2000-a>
- Manufacturer: [PROCEPT BioRobotics Corporation](https://devicerts.com/manufacturers/fda-fei-3027788423) (United States)
- Device class: Class II (US FDA)
- FDA product code: PZP
- GMDN: Rigid endoscope telescope (37084)

## Registrations and authorizations

- **GUDID** · FDA 510(k) · United States · K212835 · decision 2021-10-06 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI B614SC20001 · listed 2019-03-28 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA De Novo · United States · DEN170024 · decision 2017-12-21 · decision DENG · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: AquaBeam Scope [FDA GUDID (AccessGUDID)]
- Generic name: Rigid endoscope telescope [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: SC2000 [FDA GUDID (AccessGUDID)]; SC2000-A [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: B614SC20001 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K212835 [FDA GUDID (AccessGUDID)]
- De Novo Number: DEN170024 [FDA GUDID (AccessGUDID)]
- FDA product code: PZP [FDA GUDID (AccessGUDID)]
- GMDN term: Rigid endoscope telescope (37084) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 876.4350 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: AquaBeam Scope SC2000, PROCEPT BioRobotics Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/aquabeam-scope-sc2000-a (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/aquabeam-scope-sc2000-a.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/aquabeam-scope-sc2000-a
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.