510(k) Report

FDA applicant

Rebound Therapeutics

Irvine, CA8 decisions2018–20232 recalls

FDA records 8 decisions for Rebound Therapeutics (Irvine, CA) from 2018 to 2023: 8 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GWG (Endoscope, Neurological). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Rebound Therapeutics Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Rebound Therapeutics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 12019: 32020: 22021: 12023: 1
2018high 3 (2019) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2025

2024: 12025: 1
2018high 1 (2024) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Rebound Therapeutics by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions
  • GWGEndoscope, Neurological4decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics · 20202cite it
  • K182211Aurora Surgiscope SystemRebound Therapeutics Corporation · 20191cites it
  • K201637Aurora Evacuator +CoagRebound Therapeutics · 20201cites it
  • K203745AURORA Evacuator +CoagRebound Therapeutics · 20211cites it
  • K180372Aurora EvacuatorRebound Therapeutics · 20181cites it
  • K191861Aurora Surgiscope SystemRebound Therapeutics · 20191cites it

What has FDA decided for it lately?

  • K232618Aurora Surgiscope SystemRebound Therapeutics Corporation · 20231 recall
  • K203745AURORA Evacuator +CoagRebound Therapeutics · 2021
  • K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics · 20201 recall
  • K201637Aurora Evacuator +CoagRebound Therapeutics · 2020
  • K191861Aurora Surgiscope SystemRebound Therapeutics · 2019
  • K190075Aurora EvacuatorRebound Therapeutics · 2019
  • K182211Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
  • K180372Aurora EvacuatorRebound Therapeutics · 2018

All 6 as Rebound Therapeutics →All 2 as Rebound Therapeutics Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K201840AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator…Feb 6, 2025Class II
  • K232618AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator…Jun 7, 2024Class II