Sparrow Ascent— 510(k) K230796

Substantially Equivalent

Spark Biomedical, Inc.

FDA 510(k) clearance K230796 for Sparrow Ascent, Substantially Equivalent on 2023-06-20. Applicant: Spark Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Spark Biomedical, Inc.
Product code: Code PZR
Device class: Class 2
Regulation: 21 CFR 882.5896
Advisory panel: Neurology
Date received: 2023-03-22
Decision date: 2023-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PZR

K251246 — Sparrow Ascent2025-08-25
K233166 — NET Recovery Corp/NET Device2024-05-29
K221231 — Drug Relief v12022-06-06
K211971 — Drug Relief v12021-11-05
K201873 — Sparrow Therapy System2021-01-02

Recalls naming K230796

K-number listed on FDA's recall record

Z-2287-2025 — Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28Class II·Ongoing·Spark Biomedical Inc·20250702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230796.

Data sourced from openFDA. This site is unofficial and independent of the FDA.