ASPACH 65,000 (MODIFICATION)— 510(k) K955084
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K955084 for ASPACH 65,000 (MODIFICATION), Substantially Equivalent on 1996-01-17. Applicant: The Anspach Effort, Inc.. Device class: 1.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code HSZ
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code HSZ
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
Recalls naming K955084
K-number listed on FDA's recall record- Z-1941-2017 — BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
- Z-1963-2017 — GREEN ROTATING CRANIOTOME, BLACK MAX
- Z-1964-2017 — ADJUSTABLE DRILL GUIDE, BLACK MAX
- Z-1965-2017 — 16CM MIN INVASIVE ATTACH, BLACK MAX
- Z-1967-2017 — 22CM MICRO REVISION ATTACH, BLACK MAX
- Z-1968-2017 — 16.5CM MICRO REVISION ATTACH, BLACK MAX
- Z-1969-2017 — 9.4CM MICRO REVISION ATTACH, BLACK MAX
- Z-1970-2017 — CONTRA ANGLE ATTACHMENT, BLACK MAX
- Z-1971-2017 — 90 DEG RIGHT ANGLE ATTACH, BLACK MAX
- Z-1972-2017 — 11CM ANGLE ATTACHMENT, BLACK MAX
- Z-1973-2017 — 10.5CM ANGLE ATTACHMENT, BLACK MAX
- Z-1974-2017 — 14CM ANGLE ATTACHMENT, BLACK MAX
- Z-1975-2017 — 13.5CM ANGLE ATTACHMENT, BLACK MAX
- Z-1976-2017 — 8CM ANGLE ATTACHMENT, BLACK MAX
- Z-1977-2017 — 7.5CM ANGLE ATTACHMENT, BLACK MAX
- Z-1979-2017 — B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
- Z-1980-2017 — 6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
- Z-2017-2017 — 45 degree Contra Angle Attachment Product Usage: Pneumatic system
- Z-2018-2017 — 90 degree Contra Angle Attachment Product Usage: Pneumatic system
- Z-1983-2014 — Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955084.
Data sourced from openFDA. This site is unofficial and independent of the FDA.