ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS— 510(k) K133604
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K133604 for ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS, Substantially Equivalent on 2014-01-10. Applicant: The Anspach Effort, Inc.. Device class: 2.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code HBC
- Device class
- Class 2
- Regulation
- 21 CFR 882.4360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code HBC
view allMore clearances from The Anspach Effort, Inc.
view allAdverse events under product code HBC
product code HBC- Malfunction
- 4,715
- Total
- 4,715
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 K133604
K-number listed on FDA's recall record- Z-0916-2023 — 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
- Z-0917-2023 — 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
- Z-0918-2023 — Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
- Z-0919-2023 — 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
- Z-0920-2023 — 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
- Z-0921-2023 — Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
- Z-0922-2023 — 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
- Z-0923-2023 — 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
- Z-0924-2023 — Pediatric Craniotome Ref:CRANI-P-G1
- Z-2253-2016 — Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
- Z-1037-2015 — 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133604.
Data sourced from openFDA. This site is unofficial and independent of the FDA.