510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HAEClass II

Rongeur, Manual

21 CFR 882.4840 / Neurology
FDA source (opens on fda.gov)

HAE is the FDA product code for Rongeur, Manual, a class II device type, regulated under 21 CFR 882.4840. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HAE
Device name
Rongeur, Manual
Regulation
21 CFR 882.4840
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
37
Ingested recalls
2

Clearances, product code HAE

By decision year
37 clearances under product code HAE with a decision year between 1988 and 2026, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HAE by decision year
YearClearances
19881
19891
19904
19943
19952
20031
20072
20082
20102
20122
20132
20151
20164
20181
20202
20211
20222
20232
20251
20261

Applicants with the most clearances

Product code HAE
Applicants holding the most 510(k) clearances under product code HAE
ApplicantClearances
Baxano, Inc.6
Morpheus AG3
Integra LifeSciences Corporation2
Symmetry Surgical GmbH2
Von Zeppelin GmbH2
Ace Medical1
Aesculap Inc1
Dannoritzer Medical Instruments1
Enterprise Medical Corp.1
Fehling Instruments GmbH & Co. KG1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order