ANSPACH LUBRICATING SYSTEM II— 510(k) K970530
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K970530 for ANSPACH LUBRICATING SYSTEM II, Substantially Equivalent on 1997-05-05. Applicant: The Anspach Effort, Inc.. Device class: 1.
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code GEY
- 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 GEY
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 GEY
product code GEY- Malfunction
- 7,488
- Total
- 7,488
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 K970530
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970530.
Data sourced from openFDA. This site is unofficial and independent of the FDA.