IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK— 510(k) K971832

Name: FDA 510(k) clearance K971832
Creator: U.S. Food and Drug Administration
Published: 1997-07-31

Substantially Equivalent

M-Pact Worldwide Management Corp.

FDA 510(k) clearance K971832 for IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK, Substantially Equivalent on 1997-07-31. Applicant: M-Pact Worldwide Management Corp.. Device class: 2.

Clearance details

Applicant: M-Pact Worldwide Management Corp.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1997-05-19
Decision date: 1997-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eudora, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HOZ

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K132796 — SUNTOUCH EYE SPEAR2013-10-30
K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS2013-10-29
K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-50002009-10-23
K082460 — CENEFOM PVA SURGICAL SPEAR2008-12-15
K012196 — ULTRACELL ABSORBENT STICK2001-08-24

More clearances from M-Pact Worldwide Management Corp.

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Recalls naming K971832

K-number listed on FDA's recall record

Z-0798-2025 — Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206Class II·Ongoing·Carwild Corporation·20241022
Z-0799-2025 — Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237Class II·Ongoing·Carwild Corporation·20241022

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971832.

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