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FDA 510(k)

AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER

K-Number: K040865 · 2004-12-06

ApplicantAesculap
Decision Date2004-12-06
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap. It received FDA 510(k) clearance on 2004-12-06 under 510(k) number K040865. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER?

AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER is a medical device that received FDA 510(k) clearance on 2004-12-06. The listed applicant is Aesculap. The 510(k) number is K040865.

When did AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER receive FDA 510(k) clearance?

AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER received FDA 510(k) clearance on 2004-12-06, under 510(k) number K040865.

Who is the listed applicant for AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER?

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

What is the FDA product code for AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER?

The FDA product code for AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER is FRG.

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Other records listing Aesculap 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.

K093649AESCULAP STERILCONTAINER SK062085S4 SPINAL SYSTEMK062510AESCULAP STERILCONTAINER SYSTEMK061135MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019K043079BICONTACT HIP SYSTEM WITH U-CAPK040191BICONTACT HIP STEM AND FEMORAL HEAD

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Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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