AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS— 510(k) K954652

Name: FDA 510(k) clearance K954652
Creator: U.S. Food and Drug Administration
Published: 1996-02-14

Substantially Equivalent for Some Indications

Aesculap, Inc.

FDA 510(k) clearance K954652 for AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS, Substantially Equivalent for Some Indications on 1996-02-14. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1995-10-10
Decision date: 1996-02-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

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 HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.