Adt Mini Peritoneal Lavage Kit

Q: What is the product code of K800422?

The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.

FDA 510(k) K800422 · A.D.T. Lab Industries

Substantially Equivalent

510(k) numberK800422

Submission

Device name: Adt Mini Peritoneal Lavage Kit
Applicant: A.D.T. Lab Industries
Mchenry, IL, US
Received: February 26, 1980
Decision date: March 12, 1980
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: GBW – Catheter, Peritoneal
Device class: Class I (low risk)
Regulation: 21 CFR 878.4200
Specialty: General, Plastic Surgery

Other 510(k)s with product code GBW

510(k)	Device	Applicant	Decision
K992907	IntraducerGBW · Traditional	Taut, Inc.	10/05/1999SE
K992904	Mini-PortGBW · Traditional	Taut, Inc.	10/05/1999SE
K972112	Intraducer Port SC CATALOG#31275,31035,30915, and 31450GBW · Traditional	Taut, Inc.	12/01/1997SE
K961194	Antimicrobial Mediastinal Silicone DrainGBW · Traditional	Sil-Med Corp.	08/08/1996SE
K960426	Medicomp Flexi-Smooth Wound Drainage CatheterGBW · Traditional	Medical Components, Inc.	03/21/1996SE
K942709	Mediastinal Silicone DrainsGBW · Traditional	Sil-Med Corp.	01/04/1996SN
K933510	Argyle Turkel Safety Trocar Thoracic CatheterGBW · Traditional	Sherwood Medical Co.	02/24/1994SE
K926477	Bifurcated Suction/Irrigat Tubing Set W/Push ButtoGBW · Traditional	Core Dynamics, Inc.	11/12/1993SE
K913733	Sterile Chest TubeGBW · Traditional	Vascular Products, Inc.	10/08/1991SE
K894220	Houts Hysterectomy DrainGBW · Traditional	Helix Medical, Inc.	08/24/1989SE

More from Helix Medical, Inc.

510(k)	Device	Decision
K812297	A.D.T. Procedures TrayKMJ · Traditional	09/28/1981SE
K801754	Adt Bone Marrow Aspiration NeedleGAA · Traditional	08/20/1980SE
K801753	Adt Bone Marrow Biopsy-Aspir. NeeldeGAA · Traditional	08/20/1980SE
K800418	Adt Disposable Thin Needle AspirationFSM · Traditional	04/28/1980SE
K800417	Adt PTC Pro. Tray W/(Skinny Chiba) NeedlGAA · Traditional	04/28/1980SE
K800414	Adt Soft Tissue Biopsy TrayGAA · Traditional	04/28/1980SE
K800412	Rosenthal Needle (Disp.) Adt Bone MarrowGAA · Traditional	04/28/1980SE
K800411	Aspiration Tray W/Ferris Disp. IllinoisGAA · Traditional	04/28/1980SE
K800410	Adt Bone Marrow Biopsy-Aspiration TrayGAA · Traditional	04/28/1980SE
K800409	Adt Bone Marrow Biopsy Aspiration TrayGAA · Traditional	04/28/1980SE

Questions and answers

When was Adt Mini Peritoneal Lavage Kit cleared by the FDA?

Adt Mini Peritoneal Lavage Kit (K800422) received a 510(k) decision of Substantially Equivalent on March 12, 1980, 15 days after the submission was received.

What is the product code of K800422?

The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.