← FDA Medical Device Classifications

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

ERL · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.4250

Classification

FDA Product Code

ERL

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 874.4250

Review panel

EN

Medical specialty

Ear, Nose, Throat

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

91

Registered establishments

131

Source

Authoritative

FDA Device Classification database

Machine

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