DERMASTRIP— 510(k) K883660

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code KGX

Device class

Class 1

Regulation

21 CFR 880.5240

Advisory panel

General Hospital

Date received

1988-08-26

Decision date

1989-02-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Franklin Lakes, NJ, US

• K001240 — SERAGARD INJECTION PATCH2000-06-21
• K983368 — CARE BAND ANTIBACTERIAL BANDAGES1999-02-17
• K972914 — SYVEK PATCH1997-12-22
• K943314 — ADHESIVE BANDAGES WITH OTC DRUG1996-01-17
• K952606 — TARGETT PATCH1995-12-21

• K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
• K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
• K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
• K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
• K001364 — BD DIRECTIGEN FLU A+B2000-06-28

Injury

1,590

Malfunction

1,357

Other

3

Total

2,950

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →