MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER— 510(k) K012374
Substantially EquivalentAstra Tech, Inc.
FDA 510(k) clearance K012374 for MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER, Substantially Equivalent on 2001-08-23. Applicant: Astra Tech, Inc.. Device class: 2.
Clearance details
- Applicant
- Astra Tech, Inc.
- 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
- Special
- Location
- Northborough, MA, US
Recent devices under product code GBM
view all- K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- K211436 — Intermittent Catheter (Not Finalized)
- K200820 — SpeediCath Compact Set
- K192904 — SpeediCath Compact Set
More clearances from Astra Tech, Inc.
view all- K122078 — LOFRIC PRIMO, LOFRIC HYDRO-KIT
- K120338 — ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
- K113003 — ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
- K112138 — ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
- K110356 — ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.