HSZClass I

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

21 CFR 878.4820 / General, Plastic Surgery

HSZ is the FDA product code for Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a class I device type, regulated under 21 CFR 878.4820. As of 2026-09-10, FDA records hold 56 510(k) clearances under this code, the most recent dated 1999-07-21, and 6 recalls.

Classification record

Product code: HSZ
Device name: Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Regulation: 21 CFR 878.4820
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 56
Ingested recalls: 6

Clearances, product code HSZ

By decision year

56 clearances under product code HSZ with a decision year between 1978 and 1999, 1988 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code HSZ by decision year
Year	Clearances
1978	3
1979	2
1980	2
1981	3
1983	1
1984	2
1985	2
1986	2
1987	3
1988	6
1989	3
1990	5
1991	4
1992	3
1993	3
1994	5
1995	3
1996	1
1997	2
1999	1

Applicants with the most clearances

Product code HSZ

Applicants holding the most 510(k) clearances under product code HSZ
Applicant	Clearances
Micro-Aire Surgical Instruments, Inc.	8
The Anspach Effort, Inc.	4
American Sterilizer Co.	3
Micro Surgical Instruments Corp.	3
Tava Surgical Instruments	3
Acufex Microsurgical, Inc.	2
Anspach Mfg., Inc.	2
De Soutter Medical Ltd.	2
Romano Surgical Instrumentation, Inc.	2
Smith & Nephew Richards, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 52 companies shown, in name order