Skip to content

SpineJet® 56000

by Hydrocision, Inc.

SpineJet® 56000 is a Class II device made by Hydrocision, Inc., cleared under FDA 510(k) K200729 on 16 Apr 2020 (1 earlier submission) and listed in FDA GUDID since 25 Aug 2017 (UDI-DI 00853235007067), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK200729 Date16 Apr 2020DecidedStatusActive
United StatesGUDID listing Number00853235007067 UDI-DI Date25 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200729 decided 16 Apr 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00853235007067 listed 25 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K002764
  2. Listed FDA GUDID 00853235007067
  3. Cleared FDA 510(k) K200729

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SpineJet®
Generic name
Water jet knife system handpiece, single-use
Model / Ref / Catalog
56000
Primary DI / UDI-DI
00853235007067
510(k) Number
FDA product code
HRX
GMDN term
Water jet knife system handpiece, single-use
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Water jet knife system handpiece, single-use

Cleared under the same submission (K002764)

and 8 more cleared under K002764

Cleared under the same submission (K200729)

Similar devices in this category

Other devices filed under Water jet knife system handpiece, single-use.

Other devices from Hydrocision, Inc.

  • TenJet® 76000

    Class II

  • SpineJet® 56986

    Class II

  • SpineJet® 55500

    Class II

  • SpineJet® 56987

    Class II

See all devices from Hydrocision, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Combination product
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)