← FDA Medical Device Classifications

Clip, Tantalum, Ophthalmic

HQW · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.3100

Classification

FDA Product Code

HQW

Device class

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

Regulation

21 CFR 886.3100

Review panel

OP

Medical specialty

Ophthalmic

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

3

Registered establishments

3

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown