Product Code: LRP FDA class 1 21 CFR 878.4800

Tray, Surgical

General, Plastic Surgery

The Surgical Tray is a prepackaged set of sterile surgical instruments and supplies assembled to facilitate various surgical procedures, providing a convenient and organized collection of tools for operating room use. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRP, regulated under 21 CFR 878.4800, within the General and Plastic Surgery medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

285

Registration Numbers

286

Unique Applicants

Years Active

Research product code LRP 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: LRP
Device Class: FDA class 1
Regulation Number: 878.4800
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 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K963723	LACERATION TRAY	Nov 27, 1996	Substantially Equivalent	Grand Medical Products
K951811	OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK	May 31, 1995	Substantially Equivalent	Osteotech, Inc.
K940239	EYE TRAY	Jun 28, 1994	Unknown	Cush Medical Products
K935621	CUSTOM ENT PACKS	Mar 30, 1994	Substantially Equivalent	Associated Medical
K940646	ORTHOPEDIC TRAY PRODUCT LINE	Mar 11, 1994	Unknown	Cushindu
K940444	GENERAL SURGERY TRAY	Mar 07, 1994	Unknown	Cush Medical Products
K922126	HOSPITAL KIT ENT 1125	Jan 21, 1993	Substantially Equivalent	Savoy Medical Supply Co., Inc.
K912105	EYE TRAY	Aug 29, 1991	Substantially Equivalent	Medical Device Inspection Co., Inc.
K903963	KITS AND TRAYS FOR ONE TIME USE ONLY	Jul 29, 1991	Unknown	Apk Technology
K903962	INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE	Jul 29, 1991	Unknown	Apk Technology
K905462	PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES	Feb 06, 1991	Substantially Equivalent	Angiosystems, Inc.
K903544	CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS	Aug 31, 1990	Unknown	J.J. Skinner, Inc.
K890071	STERILE LACERATION TRAY	Jan 24, 1989	Substantially Equivalent	Mumtaz I. Malik
K883098	SITE STERILIZATION TRAYS FOR OPHTHALMIC USE	Aug 18, 1988	Substantially Equivalent	Site Microsurgical Systems, Inc.
K882275	STERILE PACK (PROCEDURAL TRAY/KITS)	Jul 18, 1988	Substantially Equivalent	East Texas Lighthouse For the Blind
K881095	KOI(TM) INSTRUMENT TRAYS	Apr 06, 1988	Substantially Equivalent	CooperVision, Inc.
K874665	SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY	Jan 20, 1988	Unknown	Precision Dynamics Corp.
K873469	TODD MEDICAL/SKILLED CARE PRODUCTS	Oct 29, 1987	Substantially Equivalent	Todd Medical, Inc.
K873290	LACERATION AND INSTRUMENT TRAYS	Sep 24, 1987	Substantially Equivalent	Advantage Medical Systems, Inc.
K873439	LACERATION TRAY	Sep 11, 1987	Substantially Equivalent	Ulti-Med Intl., Inc.
K861142	MASTER KIT B	Jul 10, 1986	Unknown	Pro-Lab, Inc.
K760497	TRAY, SERVICE	Nov 12, 1976	Substantially Equivalent	Landmark Plastics