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

Unit, Electrosurgical And Coagulation, With Accessories

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

BWA is the FDA product code for Unit, Electrosurgical And Coagulation, With Accessories, a class II device type, regulated under 21 CFR 878.4400. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BWA
Device name
Unit, Electrosurgical And Coagulation, With Accessories
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
3
Ingested recalls
0

Clearances, product code BWA

By decision year
3 clearances under product code BWA with a decision year between 1987 and 1997, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BWA by decision year
YearClearances
19872
19971

Applicants with the most clearances

Product code BWA
Applicants holding the most 510(k) clearances under product code BWA
ApplicantClearances
Alexander Mfg. Co.1
Medtronic, Inc.1
Zimmer Aspen Labs1

Companies listing this code with FDA

Companies whose registered establishments list this code