DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
Summary
Pro Med Instruments GmbH received 510(k) clearance for DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040), a HBL device. Cleared on 2024-04-24.
Details
Source
510(k) Clearance
External ID
K240319
Action Date
2024-04-24
Status
Traditional
Category
device
Product Code
HBL
Product Description
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040). Product code: HBL.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Pro Med Instruments GmbH has received 2 total clearances in our database.
Pro Med Instruments GmbH has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Pro Med Instruments GmbH have FDA actions?
Pro Med Instruments GmbH has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240319" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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