ANSPACH KNOTLESS ANCHOR— 510(k) K052572
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K052572 for ANSPACH KNOTLESS ANCHOR, Substantially Equivalent on 2005-12-05. Applicant: The Anspach Effort, Inc.. Device class: 2.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code MBI
view allMore clearances from The Anspach Effort, Inc.
view all- K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
- K183545 — Anspach Helix Dissection Tools
- K180063 — OCM-G1 Attachment
- K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
- K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
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 K052572
K-number listed on FDA's recall record- Z-1875-2014 — ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1876-2014 — ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1915-2014 — ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1916-2014 — ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052572.
Data sourced from openFDA. This site is unofficial and independent of the FDA.