HTJClass I

Gauge, Depth

21 CFR 888.4300 / Orthopedic

HTJ is the FDA product code for Gauge, Depth, a class I device type, regulated under 21 CFR 888.4300. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1994-03-23, and 3 recalls.

Classification record

Product code: HTJ
Device name: Gauge, Depth
Regulation: 21 CFR 888.4300
Device class: Class I
Review panel: Orthopedic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 3

Clearances, product code HTJ

By decision year

4 clearances under product code HTJ with a decision year between 1986 and 1994, 1986 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HTJ by decision year
Year	Clearances
1986	1
1987	1
1992	1
1994	1

Applicants with the most clearances

Product code HTJ

Applicants holding the most 510(k) clearances under product code HTJ
Applicant	Clearances
Acufex Microsurgical, Inc.	2
Buckman Co., Inc.	1
Cedar Surgical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 344 companies shown, in name order