PAEDISCOPE, MODEL # P010A AND PF011A— 510(k) K014149

Name: FDA 510(k) clearance K014149
Creator: U.S. Food and Drug Administration
Published: 2002-03-18

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K014149 for PAEDISCOPE, MODEL # P010A AND PF011A, Substantially Equivalent on 2002-03-18. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code GWG
Device class: Class 2
Regulation: 21 CFR 882.1480
Advisory panel: Neurology
Date received: 2001-12-18
Decision date: 2002-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWG

view all

K253602 — Precision S 4K Sinuscope2026-06-04
K253679 — Hydro Irrigation System2026-05-08
K243429 — HJY VisualNext 3D Endoscopic Vision System2025-05-21
K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)2025-04-09
K233391 — cCeLL - In vivo2024-08-21

More clearances from Aesculap, Inc.

view all

K242762 — Aesculap Aicon® Series Container System2025-05-13
K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set2024-12-16
K223596 — SQ.line KERRISON2023-06-29
K214041 — Aesculap AICON Container2022-12-30
K211572 — Aesculap Slim Clip Applier2021-12-13

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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