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

Instrument, Surgical, Non-Powered

21 CFR 882.4535 / Neurology
FDA source (opens on fda.gov)

HAO is the FDA product code for Instrument, Surgical, Non-Powered, a class I device type, regulated under 21 CFR 882.4535. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HAO
Device name
Instrument, Surgical, Non-Powered
Regulation
21 CFR 882.4535
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
34
Ingested recalls
2

Clearances, product code HAO

By decision year
34 clearances under product code HAO with a decision year between 1976 and 2022, 1994 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HAO by decision year
YearClearances
19762
19771
19784
19802
19822
19831
19864
19871
19883
19891
19901
19912
19921
19946
19952
20221

Applicants with the most clearances

Product code HAO
Applicants holding the most 510(k) clearances under product code HAO
ApplicantClearances
United States Surgical, A Division of Tyco Healthc7
Downs Surgical, Ltd.5
Edward Weck, Inc.3
Acra Cut, Inc.2
Cedar Surgical, Inc.2
Cerenovus, Inc.2
Medtronic, Inc.2
American V. Mueller1
Ascep, Inc.1
Cook Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 196 companies shown, in name order