ANSPACH MRI SAFE SURGICAL DRILL SYSTEM— 510(k) K040186
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K040186 for ANSPACH MRI SAFE SURGICAL DRILL SYSTEM, Substantially Equivalent on 2004-04-15. Applicant: The Anspach Effort, Inc.. Device class: 2.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code HBB
- Device class
- Class 2
- Regulation
- 21 CFR 882.4370
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code HBB
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 HBB
product code HBB- Malfunction
- 2,656
- Total
- 2,656
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 K040186
K-number listed on FDA's recall record- Z-1942-2017 — IMRI AIR CONTROL Product Usage: Pneumatic system
- Z-1943-2017 — IMRI MOTOR Product Usage: Pneumatic system
- Z-1996-2017 — IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic system
- Z-1997-2017 — IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
- Z-1998-2017 — IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system
- Z-1906-2014 — ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1907-2014 — ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***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 K040186.
Data sourced from openFDA. This site is unofficial and independent of the FDA.