Basic Dressing Change Tray SMP 102A

Q: What is the product code of K922845?

The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.

FDA 510(k) K922845 · Specialty Medical Products Co.

Unknown

510(k) numberK922845

Submission

Device name: Basic Dressing Change Tray SMP 102A
Applicant: Specialty Medical Products Co.
Little Rock, AR, US
Received: June 12, 1992
Decision date: December 29, 1992
Decision: Unknown (SEKD)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: FRG – Wrap, Sterilization
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.6850
Specialty: General Hospital

Other 510(k)s with product code FRG

510(k)	Device	Applicant	Decision
K261897	HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional	O&M Halyard, Inc.	07/02/2026SE
K252823	Dukal Crepe Paper Sterilization WrapFRG · Traditional	Dukal, LLC	05/28/2026SE
K253454	HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional	O&M Halyard, Inc.	05/18/2026SE
K251347	Sterilization Pouch/RollFRG · Traditional	Sterivic Medical Co., Ltd.	01/28/2026SE
K251177	Self-Seal Sterilization Pouch and RollFRG · Traditional	Guangdong Maidi Medical Co., Ltd.	12/12/2025SE
K250306	Chex-All Sterilization Pouches and TubesFRG · Abbreviated	Propper Manufacturing Co., Inc.	10/31/2025SE
K243179	Sterilization Pouch and RollFRG · Traditional	Yichang Xinxin Paper Products Co., Ltd.	06/26/2025SE
K250321	GCI Sterilization WrappersFRG · Traditional	George Courey, Inc.	06/06/2025SE
K243721	Self Sealing Sterilization PouchesFRG · Traditional	Wellmed Dental Medical Supply Co., Ltd.	04/25/2025SE
K250011	Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional	Turbett Surgical	04/04/2025SE

More from Turbett Surgical

510(k)	Device	Decision
K924707	Various Anesthetic Kits or TraysCAZ · Traditional	06/17/1993SEKD
K922533	IV Start Kit Custom SMP # A-ZLRS · Traditional	03/23/1993SEKD
K874596	Perforated Soaking TubeGBQ · Traditional	12/02/1987SE

Questions and answers

When was Basic Dressing Change Tray SMP 102A cleared by the FDA?

Basic Dressing Change Tray SMP 102A (K922845) received a 510(k) decision of Unknown on December 29, 1992, 200 days after the submission was received.

What is the product code of K922845?

The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.