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

Saw, Manual And Accessories

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GDR is the FDA product code for Saw, Manual And Accessories, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GDR
Device name
Saw, Manual And Accessories
Regulation
21 CFR 878.4800
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
1

Clearances, product code GDR

By decision year
2 clearances under product code GDR with a decision year between 1985 and 1987, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GDR by decision year
YearClearances
19851
19871

Applicants with the most clearances

Product code GDR
Applicants holding the most 510(k) clearances under product code GDR
ApplicantClearances
Artiberia1
Solway, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 82 companies shown, in name order