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

Apparatus, Electrosurgical

21 CFR 878.4400 / General, Plastic Surgery
FDA source (opens on fda.gov)

HAM is the FDA product code for Apparatus, Electrosurgical, a class II device type, regulated under 21 CFR 878.4400. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HAM
Device name
Apparatus, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
31
Ingested recalls
3

Clearances, product code HAM

By decision year
31 clearances under product code HAM with a decision year between 1977 and 2016, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code HAM by decision year
YearClearances
19771
19782
19814
19821
19832
19852
19861
19871
19885
19894
19901
19911
19922
19951
19991
20001
20161

Applicants with the most clearances

Product code HAM
Applicants holding the most 510(k) clearances under product code HAM
ApplicantClearances
Olsen Electrosurgical, Inc.5
Beacon Laboratories, Inc.4
Edward Weck, Inc.2
Medical Products Development, Inc.2
Bergen Mfg.1
ZOLL Medical Corporation1
C.R. Bard Inc1
Cook Ob/Gyn1
Dlp, Inc.1
Emc Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order