HNDClass I

Spatula, Ophthalmic

21 CFR 886.4350 / Ophthalmic

HND is the FDA product code for Spatula, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of 2026-09-10, FDA records hold 6 510(k) clearances under this code, the most recent dated 1986-10-31, and no recalls.

Classification record

Product code: HND
Device name: Spatula, 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: 6
Ingested recalls: 0

Clearances, product code HND

By decision year

6 clearances under product code HND with a decision year between 1976 and 1986, 1980 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HND by decision year
Year	Clearances
1976	1
1979	1
1980	2
1981	1
1986	1

Applicants with the most clearances

Product code HND

Applicants holding the most 510(k) clearances under product code HND
Applicant	Clearances
Edward Weck, Inc.	4
American V. Mueller	1
Keeler Instruments, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 153 companies shown, in name order

Recent clearances

Product code HND

Recent recalls

Product code HND

FDA records show no recalls under product code HND.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)