ANSPAHC SPEED REDUCER— 510(k) K960630
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K960630 for ANSPAHC SPEED REDUCER, Substantially Equivalent on 1996-11-19. 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 K960630
K-number listed on FDA's recall record- Z-1992-2017 — Compact Speed Reducer, 60:1
- Z-1993-2017 — Compact Speed Reducer, 60:1 Black Max
- Z-1900-2014 — ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems
- Z-1901-2014 — ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***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 K960630.
Data sourced from openFDA. This site is unofficial and independent of the FDA.