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FDA 510(k)

SCANLAN SUTURE-STATT

K-Number: K821887 · 1982-07-28

ApplicantScanlan Intl., Inc.
Decision Date1982-07-28
Product CodeHRQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCANLAN SUTURE-STATT is the device name listed in this FDA 510(k) record. The listed applicant is Scanlan Intl., Inc.. It received FDA 510(k) clearance on 1982-07-28 under 510(k) number K821887. The device is classified under product code HRQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANLAN SUTURE-STATT?

SCANLAN SUTURE-STATT is a medical device that received FDA 510(k) clearance on 1982-07-28. The listed applicant is Scanlan Intl., Inc.. The 510(k) number is K821887.

When did SCANLAN SUTURE-STATT receive FDA 510(k) clearance?

SCANLAN SUTURE-STATT received FDA 510(k) clearance on 1982-07-28, under 510(k) number K821887.

Who is the listed applicant for SCANLAN SUTURE-STATT?

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

What is the FDA product code for SCANLAN SUTURE-STATT?

The FDA product code for SCANLAN SUTURE-STATT is HRQ.

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Other records listing Scanlan 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.

K960372SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEMK945474SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERK911184SCANLAN/TAHERI VALVULOTOMEK864919SCANLAN (TM) VEIN/GRAFT HOLDERK864920SCANLAN (TM) INSTRUMENT TRAYK851825SCANLAN TUNNELER, SHEATH & TIP

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Related Devices (Code: HRQ)

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.

K920298DISPOSABLE HEMOSTATSFalcon Instruments, Inc.K895683BERNARD VESSEL APPROXIMATORApplied Medical TechnologiesK890245SURGICAL HEMOSTATSKinetic Medical ProductsK884196SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)Disposable Sterile Surgical Instruments, Inc.K881937SURGICAL INSTRUMENTSFar East Intl. Trading Corp.K861807MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)Medcomp Technologies, 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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