Intermittent Catheter (Not Finalized)— 510(k) K211436
Substantially EquivalentHollister Incorporated
FDA 510(k) clearance K211436 for Intermittent Catheter (Not Finalized), Substantially Equivalent on 2022-01-27. Applicant: Hollister Incorporated. Device class: 2.
Clearance details
- Applicant
- Hollister Incorporated
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Recent devices under product code GBM
view allMore clearances from Hollister Incorporated
view all- K253295 — Coude Sleeved IC; Coude Plus Sleeved IC
- K251468 — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
- K233524 — Sleeved IC 2 Family +4 more
- K220667 — Sleeved IC
- K213575 — Female IC (Not Finalized)
Adverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
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 K211436
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211436.
Data sourced from openFDA. This site is unofficial and independent of the FDA.