ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)— 510(k) K965016
Substantially EquivalentGibeck, Inc.
FDA 510(k) clearance K965016 for ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212), Substantially Equivalent on 1997-12-02. Applicant: Gibeck, Inc.. Device class: 2.
Clearance details
- Applicant
- Gibeck, Inc.
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CAH
view allMore clearances from Gibeck, Inc.
view all- K964377 — THERMAL REGULATION SYSTEM BLANKET
- K964382 — HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
- K960511 — GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
- K954828 — ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
- K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K965016
K-number listed on FDA's recall record- Z-0072-2023 — Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
- Z-0073-2023 — Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
- Z-0074-2023 — Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
- Z-0075-2023 — Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
- Z-0076-2023 — Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
- Z-0077-2023 — Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K965016.
Data sourced from openFDA. This site is unofficial and independent of the FDA.