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FDA 510(k)

THERMUFF BAG

K-Number: K920153 · 1992-07-01

ApplicantTechstyles
Decision Date1992-07-01
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMUFF BAG is the device name listed in this FDA 510(k) record. The listed applicant is Techstyles. It received FDA 510(k) clearance on 1992-07-01 under 510(k) number K920153. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMUFF BAG?

THERMUFF BAG is a medical device that received FDA 510(k) clearance on 1992-07-01. The listed applicant is Techstyles. The 510(k) number is K920153.

When did THERMUFF BAG receive FDA 510(k) clearance?

THERMUFF BAG received FDA 510(k) clearance on 1992-07-01, under 510(k) number K920153.

Who is the listed applicant for THERMUFF BAG?

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

What is the FDA product code for THERMUFF BAG?

The FDA product code for THERMUFF BAG is KDC.

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 Techstyles 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.

K992436GOWN BACK, MODEL 13-403N; 13-404N; 13-405NK920045DURATECH HOSPITAL TOWEL

Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, Inc.K912834SHUR-GRIPInman Medical 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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