DURA-GUARD - DURAL REPAIR PATCH— 510(k) K982282
Substantially EquivalentBio-Vascular, Inc.
FDA 510(k) clearance K982282 for DURA-GUARD - DURAL REPAIR PATCH, Substantially Equivalent on 1998-07-30. Applicant: Bio-Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Vascular, Inc.
- Product code
- Code GXQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5910
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
Recent devices under product code GXQ
view allMore clearances from Bio-Vascular, Inc.
view all- K002233 — BVI SLING
- K992537 — PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
- K983602 — CV PERI-GUARD AND VASCU-GUARD
- K983581 — OCU-GUARD AND OCU-GUARD SUPPLE
- K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
Adverse events under product code GXQ
product code GXQ- Death
- 11
- Injury
- 446
- Other
- 1
- Total
- 458
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 K982282
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 K982282.
Data sourced from openFDA. This site is unofficial and independent of the FDA.