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)

PAN SET

K-Number: K813437 · 1981-12-31

ApplicantSterile Design, Inc.
Decision Date1981-12-31
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PAN SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Design, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813437. 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 PAN SET?

PAN SET is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Sterile Design, Inc.. The 510(k) number is K813437.

When did PAN SET receive FDA 510(k) clearance?

PAN SET received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813437.

Who is the listed applicant for PAN SET?

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

What is the FDA product code for PAN SET?

The FDA product code for PAN SET is FRG.

Other records listing Sterile Design, 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.

K934688STERILE DESIGNK841960CARDIO METRICS INVASIVE PRESSURE MONITK842356CUSTOM STERILE PROCEDURE KITSK841959CARDIO METRIC CUSTOM PERFUSION TUBINGK841958CARDIO METRICS CARDIOTOMY RESERVOIRK842351STERILE DESIGN-CUSTOM STERILE IV KIT

View all 10 devices →

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.

↑