FDA 510(k)

BLADE, TONGUE

K-Number: K811157 · 1981-05-27

Decision Date1981-05-27

Product Code

DecisionSubstantially Equivalent

Device Summary

BLADE, TONGUE is the device name listed in this FDA 510(k) record. The listed applicant is Dyn-A-Med Products. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K811157. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLADE, TONGUE?

BLADE, TONGUE is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Dyn-A-Med Products. The 510(k) number is K811157.

When did BLADE, TONGUE receive FDA 510(k) clearance?

BLADE, TONGUE received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811157.

Who is the listed applicant for BLADE, TONGUE?

The FDA 510(k) record lists Dyn-A-Med Products as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dyn-A-Med Products as applicant

K844121CLAMP, TUBING, LINE K813176GEL ELECTRODE K802764PLASTIC ADHESIVE BANDAGE K802139SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY

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.