ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM— 510(k) K131053
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K131053 for ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM, Substantially Equivalent on 2013-12-31. Applicant: The Anspach Effort, Inc.. Device class: 2.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Recent devices under product code ERL
view allMore clearances from The Anspach Effort, Inc.
view allAdverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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 K131053
K-number listed on FDA's recall record- Z-2016-2017 — Otologic Curved Micro Product Usage: Pneumatic system
- Z-1667-2016 — ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
- Z-1668-2016 — ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131053.
Data sourced from openFDA. This site is unofficial and independent of the FDA.