510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971832Substantially Equivalent

Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80Cc, Ivalon Eye Drain, 400Cc, Ivalon Eye Wick

M-Pact Worldwide Management Corp., Eudora KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971832 is the FDA 510(k) clearance record for IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK, a class II device, cleared for M-Pact Worldwide Management Corp. on under FDA product code HOZ (Sponge, Ophthalmic). FDA records list 3 510(k) clearances for M-Pact Worldwide Management Corp., from to . As of , FDA records show 2 recalls naming K971832.

Clearance record

Decision date
Received
(73 days to decision)
Product code
HOZ Sponge, Ophthalmic
Regulation
21 CFR 886.4790
Device class
Class II
Review panel
Ophthalmic
Applicant
M-Pact Worldwide Management Corp. 1040 O.C.L. Pkwy., Eudora KS
510(k) summary
Summary
Third party review
No

Clearances, product code HOZ

Trailing 12 months

FDA records hold no clearances under product code HOZ in the trailing twelve months.

FDA records show no clearances under product code HOZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260