FDA 510(k)

OsteoProbe (OP-100)

K-Number: K250216 · 2025-09-11

Decision Date2025-09-11

Product CodeQGQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OsteoProbe (OP-100) is the device name listed in this FDA 510(k) record. The listed applicant is Active Life Scientific, Inc.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K250216. The device is classified under product code QGQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoProbe (OP-100)?

OsteoProbe (OP-100) is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Active Life Scientific, Inc.. The 510(k) number is K250216.

When did OsteoProbe (OP-100) receive FDA 510(k) clearance?

OsteoProbe (OP-100) received FDA 510(k) clearance on 2025-09-11, under 510(k) number K250216.

Who is the listed applicant for OsteoProbe (OP-100)?

The FDA 510(k) record lists Active Life Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoProbe (OP-100)?

The FDA product code for OsteoProbe (OP-100) is QGQ.

Other records listing Active Life Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221195OsteoProbe

Related Devices (Code: QGQ)

K221195OsteoProbeActive Life Scientific, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.