FLORET NEURO SPONGE— 510(k) K830269

Clearance details

Applicant

Ritmed, Inc.

Product code

Code EFQ

Device class

Unclassified

Advisory panel

Unknown

Date received

1983-01-25

Decision date

1983-06-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
• K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S1999-06-11
• K990974 — VITOP DRESSING1999-06-09
• K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
• K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

• K833626 — FLORET FOAM PREP SPONGE1984-02-17
• K832874 — ISOVIS WOUND PROTECTOR1983-09-26
• K830270 — ISOVIS WOUND PROTECTOR1983-06-24
• K830261 — FLORET STRUNG GAUZE SPONGES1983-06-08
• K830266 — FLORET KITTNER OR K DISSECTOR1983-06-08

• Z-2458-2026 — Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998CClass II·Ongoing·AMD Medicom Inc.·20260508
• Z-2459-2026 — Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995CClass II·Ongoing·AMD Medicom Inc.·20260508

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K830269.