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

Saw, Powered, And Accessories

21 CFR 878.4820 / General, Plastic Surgery
FDA source (opens on fda.gov)

HAB is the FDA product code for Saw, Powered, And Accessories, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
HAB
Device name
Saw, Powered, And Accessories
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
16

Clearances, product code HAB

By decision year
2 clearances under product code HAB with a decision year between 1994 and 2001, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HAB by decision year
YearClearances
19941
20011

Applicants with the most clearances

Product code HAB
Applicants holding the most 510(k) clearances under product code HAB
ApplicantClearances
Linvatec Corporation1
Surgiquip, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order