Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SECURLINE SURGICAL SKIN MARKER 1000

K-Number: K840820 · 1984-04-25

ApplicantPrecision Dynamics Corp.
Decision Date1984-04-25
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SECURLINE SURGICAL SKIN MARKER 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dynamics Corp.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840820. The device is classified under product code FZZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECURLINE SURGICAL SKIN MARKER 1000?

SECURLINE SURGICAL SKIN MARKER 1000 is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Precision Dynamics Corp.. The 510(k) number is K840820.

When did SECURLINE SURGICAL SKIN MARKER 1000 receive FDA 510(k) clearance?

SECURLINE SURGICAL SKIN MARKER 1000 received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840820.

Who is the listed applicant for SECURLINE SURGICAL SKIN MARKER 1000?

The FDA 510(k) record lists Precision Dynamics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECURLINE SURGICAL SKIN MARKER 1000?

The FDA product code for SECURLINE SURGICAL SKIN MARKER 1000 is FZZ.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Precision Dynamics Corp. 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.

K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEK994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565K994263SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540K990737'ECURLINE UMBILICAL CORD CLAMP #3500K884357PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEMK882580MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE

View all 25 devices →

Related Devices (Code: FZZ)

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.

K042555SURGICHIP TAG SURGICAL MARKERSurgichip, Inc.K915066DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.K914759BLOOM TRANSPARENT STENCILFreckles Publications, Inc.K912730ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the BlindK905143SKIN MARKERAesculap, Inc.K904559QUALTEX SKIN MARKERQualtex, 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.

↑