HADClass II

Rongeur, Powered

21 CFR 882.4845 / Neurology

HAD is the FDA product code for Rongeur, Powered, a class II device type, regulated under 21 CFR 882.4845. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2006-11-21, and no recalls.

Classification record

Product code: HAD
Device name: Rongeur, Powered
Regulation: 21 CFR 882.4845
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code HAD

By decision year

3 clearances under product code HAD with a decision year between 1991 and 2006, 1991 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HAD by decision year
Year	Clearances
1991	1
2002	1
2006	1

Applicants with the most clearances

Product code HAD

Applicants holding the most 510(k) clearances under product code HAD
Applicant	Clearances
Aesculap Inc	1
Personal Products Co.	1
The Anspach Effort, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code HAD

Recent recalls

Product code HAD

FDA records show no recalls under product code HAD.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)