ENTERON ABDOMINAL PARACENTESIS TRAY— 510(k) K874063

Clearance details

Applicant

Endovations

Product code

Code KDD

Device class

Class 1

Regulation

21 CFR 878.4800

Advisory panel

General, Plastic Surgery

Date received

1987-10-05

Decision date

1987-12-04

Decision

Unknown

Clearance type

Traditional

Location

Camp Hill, PA, US

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• K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE2001-08-13
• K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS1997-05-08
• K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY1996-04-01
• K936255 — CUSTOM CV PACK1994-03-31

• K955413 — ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER1996-02-08
• K942110 — INJECT-SNARE1994-10-13
• K934315 — ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME1994-02-28
• K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH1991-10-08
• K913870 — 5MM MICROSCISSORS1991-09-16

• Z-2386-2026 — Description/REF: PARACENTESIS KIT/ASK-00376-JHHClass I·Ongoing·ARROW INTERNATIONAL, LLC·20260421
• Z-1965-2018 — Maximal Barrier Drape; Product Codes: ASK-00376-SUClass II·Terminated·Arrow International Inc·20180411
• Z-1297-2018 — Large Volume Abdominal Paracentesis KitClass II·Terminated·Arrow International Inc·20171024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K874063.