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FDA 510(k)

SURGICAL TRAY (STERILE)

K-Number: K925022 · 1993-04-26

ApplicantCustomed, Inc.
Decision Date1993-04-26
Product CodeLRD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SURGICAL TRAY (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1993-04-26 under 510(k) number K925022. The device is classified under product code LRD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL TRAY (STERILE)?

SURGICAL TRAY (STERILE) is a medical device that received FDA 510(k) clearance on 1993-04-26. The listed applicant is Customed, Inc.. The 510(k) number is K925022.

When did SURGICAL TRAY (STERILE) receive FDA 510(k) clearance?

SURGICAL TRAY (STERILE) received FDA 510(k) clearance on 1993-04-26, under 510(k) number K925022.

Who is the listed applicant for SURGICAL TRAY (STERILE)?

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

What is the FDA product code for SURGICAL TRAY (STERILE)?

The FDA product code for SURGICAL TRAY (STERILE) is LRD.

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Other records listing Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAY

View all 36 devices →

Related Devices (Code: LRD)

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.

K984345AROMAPATCHEnvis, Inc.K932522AMSCO STERILE RECOVERIES SURGICAL PACKSAmsco Sterile Recoveries, Inc.K942789MISTASSISTThe Merlin Corp.K940133THE EXPANDACELL EAR PACKDenver Splint Co.K920842AEROSOL DELIVERY SYSTEMSHospitak, 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.

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