CPR LAP SPONGES— 510(k) K960236

Name: FDA 510(k) clearance K960236
Creator: U.S. Food and Drug Administration
Published: 1996-03-28

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960236 for CPR LAP SPONGES, Substantially Equivalent on 1996-03-28. Applicant: Custom Pack Reliability. Device class: 1.

Clearance details

Applicant: Custom Pack Reliability
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1996-01-16
Decision date: 1996-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDY

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K972634 — ULTRACELL SUCTION SPONGE1997-12-17
K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE1996-02-22
K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE1995-12-19
K953830 — KENSORB1995-10-03
K953057 — CYLINDRICAL SPONGE1995-09-14

More clearances from Custom Pack Reliability

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K960205 — CPR TRACHEOTOMY CARE TRAY1996-08-27
K960239 — CPR D & C TRAY1996-05-23
K960243 — CPR C-SECTION DELIVERY PACK1996-05-23
K960216 — CPR SUCTION CATHETER KIT1996-04-15
K960206 — CPR DRESSING CHANGE TRAY1996-04-12

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.