HNCClass I

Specula, Ophthalmic

21 CFR 886.4350 / Ophthalmic

HNC is the FDA product code for Specula, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 2002-11-01, and one recall.

Classification record

Product code: HNC
Device name: Specula, Ophthalmic
Regulation: 21 CFR 886.4350
Device class: Class I
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 11
Ingested recalls: 1

Clearances, product code HNC

By decision year

11 clearances under product code HNC with a decision year between 1976 and 2002, 1976 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code HNC by decision year
Year	Clearances
1976	3
1980	1
1983	1
1984	1
1986	2
1996	1
1998	1
2002	1

Applicants with the most clearances

Product code HNC

Applicants holding the most 510(k) clearances under product code HNC
Applicant	Clearances
V. Mueller O.V. Baxter Healthcare Corp.	3
Douglas C. Mckee & Co.	1
Eyefix, Inc.	1
Howmedica Corp.	1
Keeler Instruments, Inc.	1
Laser Center Dev. Corp.	1
Myocure, Inc.	1
Stephens Instruments, Inc	1
Visitec Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 177 companies shown, in name order