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FDA 510(k)

SURGILITE NON-WOVEN WRAP

K-Number: K822482 · 1982-09-21

ApplicantSurgilite Intl., Inc.
Decision Date1982-09-21
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGILITE NON-WOVEN WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Surgilite Intl., Inc.. It received FDA 510(k) clearance on 1982-09-21 under 510(k) number K822482. 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 SURGILITE NON-WOVEN WRAP?

SURGILITE NON-WOVEN WRAP is a medical device that received FDA 510(k) clearance on 1982-09-21. The listed applicant is Surgilite Intl., Inc.. The 510(k) number is K822482.

When did SURGILITE NON-WOVEN WRAP receive FDA 510(k) clearance?

SURGILITE NON-WOVEN WRAP received FDA 510(k) clearance on 1982-09-21, under 510(k) number K822482.

Who is the listed applicant for SURGILITE NON-WOVEN WRAP?

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

What is the FDA product code for SURGILITE NON-WOVEN WRAP?

The FDA product code for SURGILITE NON-WOVEN WRAP is FRG.

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Other records listing Surgilite Intl., 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.

K823671NO-GAUZE LAPAROTOMY SPONGEK822483MULTIPLE SCRUB SUITK822481MULTIPLE SURGICAL MASKK771531LAPAROTOMY SPONGES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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