CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET— 510(k) K870704

Clearance details

Applicant

American Pharmaseal Div. Ahsc

Product code

Code GBX

Device class

Class 1

Regulation

21 CFR 878.4200

Advisory panel

General, Plastic Surgery

Date received

1987-02-20

Decision date

1987-03-27

Decision

Unknown

Clearance type

Traditional

Location

Valencia, CA, US

• K131659 — MOERAE VEIN PREPARATION KIT2014-03-03
• K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE2008-12-17
• K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN2005-10-21
• K043515 — GRAFTSAVER2005-03-31
• K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P2002-01-10

• K874022 — PHARMASEAL WOUND IRRIGATION DEVICE1987-12-30
• K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER1987-12-03
• K874517 — PHARMASEAL RUBBER URETHRAL CATHETER1987-12-03
• K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE1987-11-06
• K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM1987-09-04

Death

16

Injury

583

Malfunction

3,578

Other

1

Total

4,178

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 →