Product Code: FSQ FDA class 2 21 CFR 878.4580

Light, Surgical, Instrument

General, Plastic Surgery

A surgical instrument light is a lighting device attached to or integrated with surgical instruments to illuminate the area of interest during operative procedures. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FSQ, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code FSQ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: FSQ
Device Class: FDA class 2
Regulation Number: 878.4580
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K932139	LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT	Jul 30, 1993	Substantially Equivalent	Aaron Medical Industries
K930686	MIDMARK SURGICAL LIGHTING SYSTEMS	Jul 30, 1993	Substantially Equivalent	Midmark Corp.
K922409	ALM ILLUMINATOR SERIES LIGHT SYSTEM	Jan 12, 1993	Substantially Equivalent	Alm Surgical Equipment, Inc.
K921848	BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT	Oct 01, 1992	Substantially Equivalent	Alm Surgical Equipment, Inc.
K803067	SURG-FLEX 10 LIGHT	Feb 26, 1981	Substantially Equivalent	Medical Products Development, Inc.
K810019	SURG-FLEX 15 SURGICAL LIGHT	Jan 23, 1981	Substantially Equivalent	Medical Products Development, Inc.
K810018	SURG-FLEX 5 SURGICAL LIGHT	Jan 23, 1981	Substantially Equivalent	Medical Products Development, Inc.