510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
EWQClass I

Saw, Surgical, Ent (Electric Or Pneumatic)

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EWQ is the FDA product code for Saw, Surgical, Ent (Electric Or Pneumatic), a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EWQ
Device name
Saw, Surgical, Ent (Electric Or Pneumatic)
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
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
0

Clearances, product code EWQ

By decision year
2 clearances under product code EWQ with a decision year between 1980 and 1985, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EWQ by decision year
YearClearances
19801
19851

Applicants with the most clearances

Product code EWQ
Applicants holding the most 510(k) clearances under product code EWQ
ApplicantClearances
Karl Storz Endoscopy-America, Inc.1
Laser Spectrum, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code