EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL— 510(k) K080802
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K080802 for EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL, Substantially Equivalent on 2008-04-30. Applicant: The Anspach Effort, Inc.. Device class: 2.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code HBE
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 HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
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 K080802
K-number listed on FDA's recall record- Z-1948-2017 — Electronic Foot Control with Direction Switch Product Usage: Electric system
- Z-1949-2017 — Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
- Z-1952-2017 — eMax2 PLUS Product Usage: Electric system
- Z-1955-2017 — Console, eMax2 Plus Product Usage: Electric system
- Z-1956-2017 — System Console, Single Port, with irrigation Product Usage: Electric system
- Z-1957-2017 — System Console, Single Port, no irrigation
- Z-2001-2017 — 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
- Z-2015-2017 — Sagittal Saw Product Usage: Pneumatic system
- Z-2019-2017 — Oscillating MICRO-SAW Product Usage: Pneumatic system
- Z-2026-2017 — Reciprocating MICRO SAW
- Z-2031-2017 — Sagittal MICRO-SAW
- Z-2032-2017 — 20.2cm Heavy Duty Long Heavy Short Attachment
- Z-0726-2014 — Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
- Z-0727-2014 — Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
- Z-0728-2014 — Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
- Z-0729-2014 — Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
- Z-1877-2014 — ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1878-2014 — ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1879-2014 — ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1880-2014 — ANSPACH***REF 98-0001***eMax Hand Control***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 K080802.
Data sourced from openFDA. This site is unofficial and independent of the FDA.