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FDA 510(k)

SPECULITE

K-Number: K963391 · 1997-12-12

ApplicantTrylon Corp.
Decision Date1997-12-12
Product CodeMPU
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPECULITE is the device name listed in this FDA 510(k) record. The listed applicant is Trylon Corp.. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K963391. The device is classified under product code MPU. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECULITE?

SPECULITE is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Trylon Corp.. The 510(k) number is K963391.

When did SPECULITE receive FDA 510(k) clearance?

SPECULITE received FDA 510(k) clearance on 1997-12-12, under 510(k) number K963391.

Who is the listed applicant for SPECULITE?

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

What is the FDA product code for SPECULITE?

The FDA product code for SPECULITE is MPU.

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 Trylon 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.

K033033VIZILITE-BLUE ORAL EXAM KITK011488SPIRABRUSH CX BIOPSY INSTRUMENTK012070ORALLITE COMPREHENSIVE EXAM TRAYK003995SPECULITE/ORALLITEK955790PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYK953364SPECULITE

View all 7 devices →

Related Devices (Code: MPU)

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.

K012070ORALLITE COMPREHENSIVE EXAM TRAYTrylon Corp.

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.

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