ANSPACH SHIELDED ATTACHMENT— 510(k) K974025
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K974025 for ANSPACH SHIELDED ATTACHMENT, Substantially Equivalent on 1998-07-06. Applicant: The Anspach Effort, Inc.. Device class: 1.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code GFF
- 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 GFF
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 GFF
product code GFF- Malfunction
- 459
- Other
- 1
- Total
- 460
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 K974025
K-number listed on FDA's recall record- Z-1940-2017 — 19cm Attachment, Black Max Product Usage: Pneumatic system
- Z-1959-2017 — 19CM ATTACHMENT, BLACK MAX
- Z-1960-2017 — 11.25CM ATTACHMENT, BLACK MAX
- Z-1961-2017 — LARGE CRANIOTOME, BLACK MAX
- Z-1962-2017 — STANDARD CRANIOTOME, BLACK MAX
- Z-1966-2017 — KEYLESS DRIVER, BLACK MAX
- Z-1978-2017 — 26.65CM ATTACHMENT, BLACK MAX
- Z-1981-2017 — 12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
- Z-1982-2017 — 5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
- Z-1983-2017 — PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system
- Z-1984-2017 — 8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
- Z-1989-2017 — Large Craniotome Product Usage: Pneumatic system
- Z-2077-2012 — .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
- Z-0829-2014 — AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
- Z-0830-2014 — Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974025.
Data sourced from openFDA. This site is unofficial and independent of the FDA.